STATISTICAL CENTER
August 2011
SWOG STATISTICAL CENTER
Introduction
SWOG is a national consortium of institutions and investigators organized for the purpose of improving
the survival of cancer patients through clinical research and sponsored by the National Cancer
Institute (NCI). The Group began in 1956 as the Southwest Cancer Chemotherapy Study Group; it
has expanded to include all modalities of cancer therapy, and institutions in all regions of the country.
Most of the studies done by the Group are designed to assess whether a regimen merits further study
(Phase II), or to compare two or more regimens (Phase III). The Group is also expanding efforts in
multi-center Phase I clinical trials, which determine the maximum tolerated dose for a given regimen.
Studies in cancer control research, including cancer prevention, symptom control and quality of life are
conducted in support of the broader mission of reducing the impact of cancer.
The Group is composed of nearly 250 institutions from across the US who enroll patients into Group
studies (Figure 1). Of these, 40 are member institutions affiliated with major academic medical centers
which formed the original nucleus of the group. There are now 179 affiliate institutions composed of
groups of community physicians affiliated with a member institution. Community Clinical Oncology
Programs (CCOP) represent another 26 collaborating institutions. These are community hospitals or
consortia with a mandate for both clinical and cancer control research.
SWOG studies are typically proposed by disease (organ site) committees, and reviewed internally for
scientific merit and feasibility prior to submission to external review by NCI through the Cancer
Therapy Evaluation Program (CTEP). The SWOG disease committees (listed in Table 1) represent
the primary organizational structure.
In 2010, there were 3,634 initial patient registrations either to SWOG therapeutic trials or by SWOG
institutions to non-SWOG therapeutic trials. In addition, 16,859 participants were registered to nontherapeutic protocols including cancer control studies, ancillary studies and to centralized follow up on
the SELECT trial. The geographic distribution of patients registered to Group studies in 2010, depicted
in Figure 2 based on residential zip codes, indicated representation from all 50 states. Patient
registrations, exclusive of the prevention trials over the past six years by study type, committee, and
institution type (Table 1) show a decrease in accrual from previous years. SWOG also accepts patient
registrations from institutions affiliated with other oncology groups, including over 900 such
registrations in 2010. There are currently 120 studies open for accrual.
The Group Chair’s Office is located at the University of Michigan at Ann Arbor, under the direction of
Group Chair Laurence H. Baker, D.O. All financial and business operations are coordinated through
this office. The Operations Office, with responsibilities for protocol development, membership, data
audits and serious adverse event (SAE) reporting, is located in San Antonio, Texas.
The SWOG Statistical Center is located at the Fred Hutchinson Cancer Research Center and at
Cancer Research And Biostatistics in Seattle, Washington. John Crowley, Ph.D., is the Group
Statistician and Director of the Statistical Center. Statistical Center staff have responsibilities for study
design and review, data collection and management, randomization procedures, reporting, data
analysis and interpretation, data and safety monitoring, quality assurance, training, and computing
system development, maintenance and support.
Page 2
August
2011
SWOG STATISTICAL CENTER
Figure 1
SWOG Institutions
August
2011
MEMBER
CCOP
Affiliate
SELECT
Page 3
SWOG STATISTICAL CENTER
Figure 2
SWOG 2010 Registrations
Page 4
August
2011
SWOG STATISTICAL CENTER
TABLE 1: SWOG INITIAL REGISTRATIONS TO THERAPEUTIC
AND NON-THERAPEUTIC STUDIES
Jan 2006
Dec 2006
Jan 2007
Dec 2007
Jan 2008
Dec 2008
Jan 2009
Dec 2009
Jan 2010
Dec 2010
Total
5,416
5,671
6,108
7,363
6,484
31,042
13
854
3,021
3,888
24
587
3,742
4,353
47
489
4,785
5,321
50
533
5,703
6,286
32
877
2,755
3,664
166
3,340
20,006
23,512
Non-therapeutic
Study
1,528
1,318
787
1,077
2,820
7,530
Committee
Brain
Breast
Cancer Control
GI
GU
GYN
Head/Neck
ICAS
Leukemia
Lung
Lymphoma
Melanoma
Myeloma
Translational
1
1,617
2
453
702
4
74
104
619
965
390
240
234
11
0
2,159
5
650
531
0
44
18
753
830
368
159
136
18
0
3,021
2
611
807
0
1
0
841
274
285
108
118
40
0
4,123
474
471
810
0
0
0
651
340
144
111
198
41
0
1,595
2,527
475
450
57
0
0
219
567
224
55
239
76
1
12,515
3,010
2,660
3,300
61
119
122
3,083
2,976
1,411
673
925
186
1,707
886
1,478
220
1,820
955
1,418
108
1,840
913
1,327
150
2,165
988
1,657
159
3,168
713
1,440
90
10,700
4,455
7,320
727
36
0
452
2
30
289
57
0
122
75
14
39
9
1,125
27
0
437
2
45
295
72
3
185
169
74
48
13
1,370
18
3
573
0
98
376
41
0
233
311
178
16
31
1,878
25
6
727
0
134
597
0
3
367
241
244
17
33
2,394
11
0
317
0
39
293
0
8
226
48
95
18
18
1,073
117
9
2,506
4
346
1,850
170
14
1,133
844
605
138
104
7,840
Total
Study Type
Therapeutic Study:
Phase I
Phase II
Phase III
Institution
Member
Affiliate
CCOP
UCOP
Other Groups:
ACOSOG
BMT-CTN
CALGB
COG
CTSU-NOS
ECOG
EORTC
GOG
NCCTG
NCIC-CTG
NSABP
RTOG
Other
Total Other Groups
August
2011
Page 5
SWOG STATISTICAL CENTER
Main Objectives of the Statistical Center
Study Design
The Statistical Center has a fundamental role in clarifying study objectives and in designing statistically
sound studies to meet those objectives.
Biostatisticians participate in the development of proposed protocols, particularly in regards to
experimental design, sample size and feasibility. Biostatisticians also perform statistical research on
the efficient design, conduct and analysis of cancer clinical trials and cancer control research, with
special emphasis on designs for translational studies. Research is being done on the analysis of
survival data, on design and analysis strategies for clinical trials, on monitoring strategies for Phase III
studies, and on methods for the analysis of high-dimensional data.
Protocol Review
The Statistical Center reviews all protocols for logical consistency, completeness, and design integrity
to assure that study conduct is not compromised through use of an inaccurate protocol document.
Biostatisticians and Data Coordinators provide independent internal review of study protocols with
respect to the appropriateness of the design and data collection for the scientific aims, for consistency
with general guidelines, and for clarity of eligibility and other study requirements.
Data Quality Control and Monitoring
The Statistical Center collects, reviews, manages and stores data from all active SWOG studies, and
follows quality control and review procedures which ensure the integrity of the data evaluation.
Web-based software created at the Statistical Center provides for registration of all patients on all
studies, and for randomization of patients when appropriate. Data Coordinators review all data
collected and request clarification as necessary. Performance statistics on timeliness of data
submitted by each institution are routinely reviewed as part of an effort to improve data submission
throughout the Group.
Software Development and Maintenance
The Statistical Center is responsible for creating and supporting many custom software applications
used by the institution membership, as well as internal staff at the Statistical Center, Group Chair’s
Office, and Operations Office. Staff also evaluate and utilize commercial software products as
applicable. These applications support the research and goals of the Group, including data collection,
data management, data retrieval and analysis.
Information Technology
The Statistical Center evaluates, develops and maintains state-of-the-art information technology to
support its objectives. The Information Technology staff provide and sustain hardware support for
computer processing and storage of data.
Analysis and Publication
The Statistical Center is responsible for statistical analysis and interpretation of all SWOG studies.
Biostatisticians analyze and publish the results of studies in conjunction with the Study Coordinators
(principal investigators). They also provide regular summaries of ongoing trials for the Group’s twice
yearly Report of Studies, and appropriate analyses for abstracts and scientific publications.
Statistical Research
The Statistical Center has an active research program addressing ongoing design and analysis issues
important to the conduct of cancer clinical trials and to ancillary biologic studies. While separately
funded, this methodologic research draws from the work of the Group, and contributes through the
development of more efficient trial designs and more efficient statistical analyses.
Page 6
August
2011
SWOG STATISTICAL CENTER
Education and Collaboration
The Statistical Center plays a key role in the training of new Clinical Research Associates (CRAs) and
of Young Investigators in the Group. Biostatisticians and Data Coordinators educate investigators,
nurse oncologists and CRAs in statistical analysis, research design and the utilization of the most
advanced scientific and data management strategies.
Communications
Statistical Center staff work with the Group Chair and other investigators in the Group to improve the
quality of clinical trials through the use of improved data collection forms, reproducible data definitions
and economical data flow, and efficient use of Statistical Center resources.
Statistical Center Functions and Organization
The SWOG Statistical Center is directed by the Group Biostatistician, John J. Crowley, Ph.D., and is
located at both the Fred Hutchinson Cancer Research Center (FHCRC) and Cancer Research And
Biostatistics (CRAB) in Seattle, Washington. Most doctoral level statisticians also have faculty
appointments in the Department of Biostatistics at the University of Washington located approximately
three miles from the Statistical Center.
The FHCRC-housed Statistical Center component is located in the Public Health Sciences building on
the FHCRC campus, about a mile from CRAB offices in downtown Seattle. The two physically
separate staffs are connected electronically. Statisticians are primarily located at FHCRC along with
minimal administrative support.
All other operations, including data management, software
development, and network administration are performed by the Statistical Center housed at CRAB.
The primary work of the Group is accomplished through disease and/or discipline committees. To
support this, each committee has at least one statistician and one data coordinator assigned to
support scientific activities. Prior to any study initiation, statisticians review the protocol for feasibility,
experimental design, and key elements of data collection protocols, define randomization schema and
data analysis plans and calculate the appropriate number of patients needed to answer the research
objectives. Statisticians also perform analyses of study results for the semi-annual Report of Studies,
for the data and safety monitoring committee (where appropriate) and for publications.
Data coordinators review protocols for clarity and consistency, monitor registrations and
randomizations of patients to studies, review patient data forms for consistency and completeness,
help in study monitoring, coordinate and send electronic communications to Clinical Research
Associates (CRAs), and direct initial and ongoing training and support for CRAs through online training
services and the once yearly Clinical Trials Training Course.
Applications developers maintain the Statistical Center's hardware and software infrastructure and
develop new software as needed to accomplish the Statistical Center's objectives. Each staff member
at both FHCRC and CRAB has access to the network to carry out all required activities.
Administrative and clerical tasks are carried out by the coordinating center manager, administrative
coordinator, administrative assistants, and office workers. Finance oversight is provided by grants and
contracts administrators.
The Statistical Center organizational structure is presented in Figure 3, followed by the current staffing.
August
2011
Page 7
SWOG STATISTICAL CENTER
FIGURE 3 SWOG STATISTICAL CENTER ORGANIZATIONAL CHART
Director/Group Statistician
Deputy Director
Coordinating Center Manager
Associate Director, Cancer Control &
Prevention
Coordinating Biostatisticians
ADMINISTRATION
Program Manager
Finance/Administrative Coordinator
BIOSTATISTICIANS
Disease Committee & Cancer Control Faculty
Biostatisticians
Behavior Scientist
Staff Biostatisticians
INFORMATION TECHNOLOGY (IT)
IT Program Director
Senior System Engineer
Systems Administrator
DataBase Administrator
Project Manager
System Support Specialists
APPLICATIONS DEVELOPMENT (APP DEV)
Applications Development Director
App Dev Systems Analyst/Programmer Supervisor
Program Manager
Case Report Forms Programmer
App Dev System Analyst/Programmers
SAS Programmer
Software Testing Lead
Technical Support Analyst
THERAPEUTIC STUDIES
DATA OPERATIONS
Data Operations Manager
Data Operations Supervisors
Data Operations Quality Assurance Coordinator
Data Coordinators
Data Control Technicians
PREVENTION STUDIES
Program Director
PROSTATE CANCER PREVENTION TRIAL
(PCPT)
Biostatisticians
SELENIUM and VITAMIN E CANCER
PREVENTION TRIAL (SELECT)
Biostatisticians
Data Operations Manager
Data Operations Supervisor
Administrative/Technical Assistant
Data Coordinators
Data Control Technicians
Retention & Adherence Manager
Page 8
August
2011
SWOG STATISTICAL CENTER
FIGURE 4 SWOG STATISTICAL CENTER STAFF
3
John Crowley, PhD, Director
2
Jacqueline Benedetti, PhD, Deputy Director
1
Evonne Lackey, CCRP, Coordinating Center Manager
2
Garnet Anderson, PhD, Associate Director, Cancer Control & Prevention
2
Cathryn Rankin, MS, Coordinating Biostatistician, Therapeutics
2
Joseph Unger, MS, Coordinating Biostatistician, Cancer Control & Prevention
Administration
1
Angela Smith, BA, Program Manager
2
Tess Hurley
1
Applications Development
Ron Bredehoeft, Director
Chris Cook, MA, Applications Development
Manager
David Law, BS, Systems Analyst Supervisor
Amy Edwards, BS, BA
Bradd Olund
Carlos Marin, BS
Darlene Davis, BS
Deborah Sopher, MS
Devin Kearns, BA
Keith Hodo, BA
Matt Scott, AAS
Megha Agrawal
Rick Mize
Taylor Phillips, BA, BS
Teresa Chern, AAS, MCSE
Yoko Rivers, BA
Biostatistics
2
Amy Darke, MS
1
Antje Hoering, PhD
2
Benjamin Ely, MS
2
Bryan Goldman, MS
3
Cathee Till, MS
2
Catherine Tangen, DrPH
2
Danika Lew, MA
2
Holly Gundacker, MS
2
James Moon, MS
3
Katie Arnold, MS
2
Mary Redman, PhD
2
Megan Othus, PhD
2
Michael LeBlanc, PhD
2
Phyllis Goodman, MS
1
Rachael Sexton, MS
1
William Barlow, PhD
1
Data Control Technicians:
Houstyn Evans
Scott Terry
1
Prevention Studies & Data Management
1
Jo Ann Hartline, MPH, Program Director
1
Karen Anderson, Retention Manager
1
Monica Yee, BA, Data Operations Manager
1
1
Data Coordinators:
Dona Marrah, Data Operations Supervisor
Diane Liggett, BS
Roxanne Topacio
Cristine Grepo
Amy Johnson, BA
1
2011
Data Coordinators:
Brian Zeller
Christine McLeod
Iris (Cat) Syquia
Jean Barce, BA
Jennie Barrett
Jeri Jardine, BS
Larry Kaye, BA
Tracy Maher, BS
Administration:
Jason Harris-Talley, BA, Administrative/Technical
Assistant
Information Technology
Keith Goodman, MA, Chief Technology Officer
Patrick Durham, BS, Program Director
Alec McKeown
Brent Watkins
Jane Xie, BA
Steve Dong-Lee, BA
Steven Briggs, BA
Terry Lynch, BA
August
Therapeutic Studies - Data Management
Rodney Sutter, Data Operations Manager
Camille White, BS, CCRP,
Data Operations Supervisor
Laura Kingsbury, MRT,
Quality Assurance Coordinator
Stephanie Edwards, Data Operations Supervisor
Data Control Technicians:
Claudia Vio, AA, AAAS
Ginnie Bauman, AA
Jackie Bernier, BS
1
2
1
3
Location: CRAB, FHCRC, Both
Page 9
SWOG STATISTICAL CENTER
TABLE 2: STATISTICAL CENTER DISEASE AND ADMINISTRATIVE
COMMITTEE TEAMS
Disease Committee
Data Coordinators
Biostatisticians
Breast
Iris (Cat) Syquia
Jean Barce
Jennie Barrett
Larry Kaye
William Barlow
Danika Lew
Gastrointestinal
Christine McLeod
Rodney Sutter
Stephanie Edwards
Jacqueline Benedetti
Bryan Goldman
Cathryn Rankin
Holly Gundacker
Genitourinary
Brian Zeller
Jean Barce
Rodney Sutter
Catherine Tangen
Benjamin Ely
Bryan Goldman
Leukemia
Camille White
Jean Barce
Tracy Maher
Megan Othus
Lung
Brian Zeller
Camille White
Larry Kaye
Mary Redman
John Crowley
James Moon
Lymphoma
Iris (Cat) Syquia
Jeri Jardine
Michael LeBlanc
Bryan Goldman
Joseph Unger
Melanoma
Jennie Barrett
Megan Othus
James Moon
Myeloma
Jeri Jardine
Laura Kingsbury
Tracy Maher
Antje Hoering
John Crowley
Rachael Sexton
Early Therapeutics
Christine McLeod
Laura Kingsbury
Antje Hoering
Rachael Sexton
Holly Gundacker
Administrative Committees
Radiation Therapy
Danika Lew
Surgery
James Moon
Pathology
Larry Kaye
Holly Gundacker
Cancer Control & Prevention Committees
Jo Ann Hartline
(Administrative Director)
Garnet Anderson
Joseph Unger
Cancer Survivorship
Joseph Unger
Outcomes and Comparative Effectiveness
William Barlow
Joseph Unger
Molecular Epidemiology
William Barlow
Prevention
Garnet Anderson
Joseph Unger
Symptom Control and Quality of Life
Garnet Anderson
Joseph Unger
Page 10
August
2011
SWOG STATISTICAL CENTER
Major Accomplishments
In fulfilling these objectives, major accomplishments during the years 2005-2010 are listed below.
Of special note, this period of time included a major transition to Web-based applications for many
functions of the Group. In addition to online patient registration, Web-based software applications are
now used to collect patient data, review submitted data, collect Study Coordinator reviews, and track
specimens.
Study Design and Conduct
Developed a Phase II/III design featuring an early interim analysis based on a shorter term endpoint.
Conducted 122 Phase II and 39 Phase III Group trials.
Investigated the properties of phase III designs with targeted agents under varying assumptions of target
measurement and agent effectiveness.
Investigated the properties of phase II/III designs which incorporate early Phase II evaluation using
surrogate outcomes.
Transitioned the Selenium and Vitamin E Cancer Prevention Trial (SELECT) to centralized follow-up by
Statistical Center staff, establishing a new paradigm for participant contact and follow-up in a large-scale
trial environment.
Activated and completed S0701, a study of Helicobacter Pylori eradication, based in Latin America and
requiring systems and materials in Spanish.
Protocol Review
Since 2006, the Statistical Center Protocol Review Committee (PRC) has reviewed approximately 65
protocols. This committee reviews 10 - 15 protocols each calendar year.
Enhanced the Statistical Center’s protocol review guidelines and implemented a mechanism to engage
Study Coordinators in the Protocol Review Committee’s proceedings.
Re-organized the PRC to include participation by data coordinators, the Director of Operations and
Protocols, and protocol coordinators in San Antonio via conference call, and to allow Study Coordinator
participation.
Expanded the role of PRC to include pre-capsule statistical review of all study designs.
Data Quality Control and Study Monitoring
Mandated online data submission for all SWOG institutions for SWOG-coordinated studies.
Converted to the Common Terminology Criteria – Adverse Events (CTCAE) version 4.0.
Developed enhancements to the CRA Workbench website, including online reports such as expectation
and query reports, and new on-demand accrual reporting.
Revised the formal training program and the Data Operations Procedure Manual to reflect updated
workflow needs for Web-based data management.
Revised the CRA Manual to update guidance on electronic data capture and management procedures,
and to update disease staging criteria where appropriate.
Managed the conduct and/or follow-up of multiple large intergroup trials, including SWOG S9346, S9415,
S9623, S0033, S0205, S0221, S0226, S0307, S0421 and S0518.
August
2011
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SWOG STATISTICAL CENTER
Continued the internal quality assurance program to audit the data coding quality of Data Coordinators,
and to provide continuing education as needed.
Managed more than 25,000 new therapeutic registrations and 24,000 therapeutic patients in follow-up.
Software Development and Maintenance
Revised database infrastructure to allow clinical research associates to amend successful data
submissions online.
Created alternate authentication web service to allow non-SWOG users to access and use online data
submission tools.
Added dynamically-generated expectations for on-study data (e.g., Treatment Forms) to the expectation
report.
Completed the “rando node” requirements to use the Oncology Patient Enrollment Network (OPEN)
application for enrollments on studies activating on or after October 2009.
Created an online Study Coordinator evaluation application. This application allows Study Coordinators
to access the electronic research charts for their studies, and to review and comment on data
coordinator evaluations.
Updated the Specimen Tracking System to collect and communicate assay results for real-time protocol
decisions such as eligibility and treatment.
Created a participant tracking tool for Statistical Center staff to follow-up on mail and phone contacts with
over 17,000 SELECT participants registered to centralized follow-up.
Modified existing systems to implement CTCAE 4.0 and to allow conversion of trials based on older
CTCAE versions.
Evaluated the options for the new Medidata Rave system including beginning processes for
implementation in 2011-2012.
Information Technology
®
Introduced and implemented virtual server technology, VMware , for more efficient use of server
resources, standardized server deployment and management, and enhanced backup and disaster
recovery.
Continued ongoing enhancement of best practices for security and systems management including
additional monitoring of servers and services.
Implemented additional layers of network security, including enhanced intrusion monitoring.
®
Upgraded Citrix terminal services and deployed two-factor authentication.
®
Deployed Cisco IronPort
upgrade to the system.
®
®
email security appliance for anti-spam and anti-virus protection as an
™
Implemented Dell KACE systems management appliances to support efficient, consistent and reliable
installation of operating systems and applications on workstations and servers.
Hardened security and procedures to meet compliance requirements for 21 CFR Part 11 and the Federal
Information Security Management Act (FISMA) of 2002.
Page 12
August
2011
SWOG STATISTICAL CENTER
Analysis and Publication
Co-authored approximately 366 publications.
Continued the development of analytic software, including the Statisticians’ Report Worksheet (SRW) for
producing the Report of Studies, and programs for exploratory and longitudinal data analysis. Software
was updated to display data (e.g., adverse events, response) by cycles or other pre-defined segments of
protocol treatment. Additional upgrades were implemented to use treatment attribution in reporting
adverse events.
Completed conduct of a large prevention trial, the Selenium and Vitamin E Cancer Prevention Trial
(SELECT). Primary study results were published in the Journal of the American Medical Association in
January 2009. Since 2006 there have been 22 publications and abstracts based on SELECT.
Numerous publications have been generated by The Prostate Cancer Prevention Trial (PCPT).
Published the second edition of Clinical Trials in Oncology, a book co-authored by three Statistical
Center faculty members (translated into Japanese in 2004). Offered short courses based on this text.
Edited the Handbook of Statistics in Clinical Oncology, which included contributions from five Statistical
Center faculty members. A revised edition was published in 2006.
Statistical Research
Made advances in statistical methods for therapeutic and prevention trials, for quality of life studies,
translational research and for the analysis of high-dimensional data, as evidenced by presentations at
national meetings and publications. Developed and improved tools for the design of trials and made
them available on the Web.
Authored approximately 60 independent research publications.
Education and Collaboration
Offered training programs for new and experienced CRAs on the use of new Web tools.
Continued and revised annual Clinical Trials Training Course (CTTC) for CRAs, Nurse Oncologists and
other members new to the Group.
Created an online version of the Clinical Trials Training Course (CTTC) for CRAs.
Contributed to the development and conduct of a Young Investigators Workshop, an intensive training
program designed to teach clinical trials principles to new researchers.
Participated with a group of Japanese investigators in a series of clinical trials workshops.
Communications
Serve the national oncology community via Faculty Biostatisticians’ participation on external committees
such as data monitoring committees, NIH review panels, American Joint Commission on Cancer task
forces, and editorial boards.
August
2011
Page 13
SWOG STATISTICAL CENTER
Computing Infrastructure
Information Technology Environment
The computing infrastructure at the Statistical Center is a complex environment that utilizes a variety of
resources to support SWOG research trials. These resources include a secure technology infrastructure
with hardware that hosts applications for electronic data capture (EDC), data management and statistical
analysis.
®
®
Statistical Center computing resources are housed on the Microsoft Windows Server 2008 and
®
Windows Server 2003 network operating systems, primarily running in a virtual environment utilizing
®
VMware technology. The key services include the databases, email, Internet Web services, application
®
and file sharing, electronic document and image management, Cardiff Teleform case report form design
and submission, batch application processing, disaster recovery, virus protection services, security
®
monitoring and notification, Citrix -based terminal services, remote access, desktop configuration and
network monitoring/management applications. This infrastructure supports statistical applications and
services used by SWOG Biostatisticians at Fred Hutchinson Cancer Research Center (FHCRC) and
Cancer Research And Biostatistics (CRAB), plus the applications used by SWOG member institutions
and staff at the Group Chair’s (Ann Arbor) and Operations (San Antonio) offices.
Data collection, data management, and data reporting applications are designed to efficiently and
securely collect, manage and report study data submitted by Clinical Research Associates (CRAs).
Through the SWOG CRA Workbench website, CRAs can access applications that support patient
registration, clinical data submission, specimen tracking, and Web user administration. CRAs may also
utilize applications to support the unique requirements of early therapeutic studies and the collection of
research images. Data management applications include patient data evaluation, research chart
management, and Study Coordinator evaluation. Data reporting activities are supported with a
Biostatistician’s reporting application. Another application supports the management of SWOG
membership information.
For a diagram depicting the major SWOG application resources see Figure 5. These applications are
housed at the Statistical Center at CRAB with access allowed through secure connections via the
Internet.
Page 14
August
2011
SWOG STATISTICAL CENTER
Figure 5: SWOG Application Resources
Desktop Systems and Network
Staff at FHCRC and CRAB primarily utilize a workstation with an Intel dual-core, Intel Core 2 and
®
®
Pentium D system. Each desktop PC runs Microsoft Windows XP Professional. Over 35 desktop
applications are supported. All workstations access Statistical Center servers and the Internet. The
Statistical Center database, file storage, and related services are housed at CRAB. Statistical Center
staff at Fred Hutchinson Cancer Research Center (FHCRC) access CRAB resources via a Web browser
®
over a secure network connection to Citrix terminal services. Both CRAB and FHCRC have
independent secure connections to the Internet.
Virtualized Windows Network
®
Virtual server technology using VMware ESX Server has been introduced at the Statistical Center to
enhance support of the distributed architecture while making more efficient use of hardware resources
by sharing processor and memory with multiple virtual Windows servers. Other benefits of this
technology include scalability for faster deployment of new systems that meet the requirements for users
and federal regulations, high availability, and streamlined disaster recovery. This virtualized Windows
infrastructure supports the modified, distributed architecture used by the SWOG Statistical Center. In
this distributed architecture the majority of the Windows® 2008 and 2003 servers perform different
August
2011
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SWOG STATISTICAL CENTER
functions in order to separate key server applications and to improve performance, security, day-to-day
management and recoverability.
SWOG staff and member institutions utilize more than 60 network servers supporting applications and
services. Included are several development and test servers that support developer applications, test
databases, and Web Internet Information Server application development and test environments.
VMware-based virtual servers are housed on an array of eight or more physical servers with a minimum
of two dual-core Xeon (or better) processors with 8 to 16 Gigabytes (GB) of memory. Some key
services, such as firewall, mail relay, and Web proxy, continue to be supported on individual physical
servers to enhance both security and performance. Systems include fault-tolerant disk subsystems and
4- to 24-hour on-site maintenance services.
Key network server services and systems applications supported at the Statistical Center are listed in the
following table.
Table 3: Network Server Services and Systems Applications
Camellia© C/S batch services
R(GNU S) microarray analysis
Cardiff™ Teleform® form recognition
SAS® and Splus® statistical analysis
Cardiff™ RightFax® digital fax system
Shavlik NetChk™ systems update manager
Citrix® secure terminal services
Cisco® IronPort® email anti-spam, anti-virus
Ecora© Auditor server change management
SolarWinds® ipMonitor server monitoring
Lyris™ list server
Symantec™ Backup Exec disaster
recovery
Microsoft® Exchange Email post office
Dell® KACE™ systems management
appliances
Microsoft® IIS Web Servers
TNT© ELM server event monitoring
Microsoft® SQL Server database
Trend Micro™ virus protection
Numara Track-IT® service desk
VMware® Virtual Center virtual server
manager
Oracle® database
vRangerPro® virtual server backup
Quest® Toad for Oracle database management
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August
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Regulatory Compliance
Processes and procedures involving network services and data management applications are influenced
by federal requirements for computer, network and data security.
The Statistical Center has established and maintains compliance with the Federal Information Security
Management Act (FISMA) of 2002. Compliance with FISMA 2002 was established at the request and
requirement of member federal institutions, in particular facilities run by the US Department of Veterans
Affairs. This compliance, including the required security and management processes covered under
FISMA 2002, benefits all SWOG institutions.
The Statistical Center has also established processes, procedures and systems to support studies that
are required to meet Food and Drug Administration (FDA) requirements for electronic records and
electronic signatures as noted under Title 21 CFR Part 11 of the Code of Federal Regulations.
Development continues on compliant Web-based electronic data entry applications.
Disaster Recovery
Disaster recovery and data backup and archival are based on best practices in data protection with
particular emphasis on regulatory requirements. Network administrators routinely review and compare
current practices with existing policies and procedures. Updates to policies, procedures and training are
incorporated as appropriate. Three tape library systems and assorted stand-alone tape drives are used
for backup data for data recovery and permanent archival. Current technology uses SDLT and LTO3
tape types and systems are retained to read older media.
Contingency Plans
All servers are backed up to tape. Production databases are backed up fully each day. Database
change logs are backed up to disk every hour. Application and file servers are backed up fully on the
weekend and differentially each night during the week. Backup media are transferred to secure fireproof
cabinets daily and rotated to a bonded, secure off-site storage facility (vault) on a weekly basis, at
minimum. The most recent, and critical backups are stored in a fireproof safe with combination lock.
Original software, media, and accompanying installation paperwork are stored in centralized fireproof
cabinets.
Servers and data are hosted on fault tolerant disk subsystems. Disk imaging and file recovery
applications are used to speed up restoration of key file servers including database systems. This
system has been tested and is used as a part of normal day-to-day operations, including routine data
restorations and planned server construction, migrations, and upgrades.
Emergency mode plans cover varying levels of disaster recovery and are developed to address the
severity and extent of disaster. This may include a combination of manual and electronic replacement
systems until such time that critical network services can be re-instated to full functionality. A Liebert
battery UPS provides conditioned power and logical shutdown of servers in the event of complete power
loss. Continuing improvements to the Disaster Recovery and Business Continuity procedures are
planned for the coming year.
Network Security
Network security is based on best practices for electronic computing and networking and to comply with
required regulations. Security, and disaster recovery, is addressed through a defense-in-depth
approach. Multiple layers of defense are utilized to address potential security vulnerabilities. Policies
and procedures for disaster recovery are modified as needed and reviewed annually. Outside
professional consultation, review and auditing provides additional feedback and results in updates to
policies, procedures and training as appropriate.
Access Controls
Physical security is managed through restricted access utilizing keycards and badges. Procedures are
in place to record and track visitors who are then escorted by authorized staff. Sensitive areas, including
the data center, cable closets and media storage, are uniquely-keyed with limited access and monitored
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through video surveillance. Staff workstations are located in specific work areas that are locked after
normal business hours.
All staff members are required to read and sign software, network, computer and data protection
policies. These policies clearly outline and define proper use of desktop computers, email, access to
other network services, software usage, protection of patient information and other related practices.
Operating System policies may further restrict staff from inappropriate computer or software usage.
Network software monitoring applications track software use by user and workstation. Passwords are
not transmitted via email or over the Internet.
Access to the network and Oracle database is controlled according to the user’s role and job function.
SWOG Statistical Center staff have three accounts for the network, database, and Web applications.
The SWOG Operations Office and Group Chair’s Office staff, and SWOG membership (investigators,
CRAs, etc.) have just one account for access through the Web applications. Each of these is described
below.
Network Resources
®
®
Access to network resources is secured through Microsoft Windows Server 2003 Active Directory
technology. Domain level authentication is used to control access to network services. Security policies
are enforced through Windows active group policy, applied to users, workstations and servers. Logon
sessions have enforced password protected screen savers that lock the systems after 20 minutes of
inactivity. Both failed and successful user authentication attempts are centrally logged. Failed logon
attempts are formally reviewed as part of a daily checklist procedure. The highest level account for
network administration is renamed and changed periodically to increase security.
®
SWOG Statistical office employees housed at FHCRC access resources via secure Citrix connectivity
which provides both data protection via strong 128-bit SSL encryption and user network-level
authentication through Microsoft Active Directory services. A security initiative implemented in 2009
®
increases user authentication security by adding RSA SecurID token-based technology to all remote
access connectivity. This increased security complies with the industry security best practice standard of
two-factor authentication for remote user access.
Oracle Database
Oracle accounts are user-based, and are created only for those who need direct access to the database
as part of their job function. Individually identifiable patient data, collected only at the time of registration,
are stored in a secure table where read and write access is highly restricted and requires prior approval
of the Group Statistician. All accounts have controlled access to resources based on individual user
account definitions.
Web-based Software Applications
Access to the network and Oracle database from outside the central offices is controlled through
software applications. Access to the software applications requires a SWOG Roster ID and valid
password, with the exception of Specimen Tracking that allows non-SWOG users to access the
application using their Cancer Trials Support Unit (CTSU) username and password (see Specimen
Tracking described later in this section). Permissions are role-based and application-specific, and are
managed by local Web User Administrators (WUAs) appointed for each institution or office (see WUA
described later in this section).
For network, database, and Web user accounts, all users are required to use “strong” passwords (those
with a combination of lower and upper case alphabetic characters, numbers and special characters) to
reduce the risk of password cracking.
Media Controls
All software media and licensing are filed in fireproof file cabinets which are stored in restricted areas.
Only authorized personnel may access original software media and licensing. All software upgrades to
workstations, servers or other systems are done by Information Technology staff or by explicit
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permission of the Information Technology Program Director. In rare situations, some users may install
specified software licensing.
On-site backup media are stored in either a fireproof safe or fireproof cabinet located in restricted areas.
All off-site backup media are stored in a secure, bonded, protected vault at professional facilities.
All old server and PC disk drives, CDs, portable media and other storage material are destroyed by a
bonded, professional media destruction company.
All server rooms, server configuration areas and media storage are in restricted access locations. Signs
are clearly posted on restricted areas, limited to access by authorized staff. All server rooms and server
configuration areas have security cameras, which record entry and exit 24 x 7 hours per week. All
servers are set with screen/keyboard locks through Windows active directory group policy.
Information Technology Security and Monitoring
®
Redundant Cisco routers are configured as the first level of security in assuring network security.
Inbound and outbound access is then monitored and controlled through redundant firewalls utilizing
®
Check Point firewall software. The firewalls and other border security is monitored 24x7.
Secure Socket Layer (SSL) encryption is used on Web and email servers. Secure File Transfer Protocol
(SFTP) is used for the file transfer with remote clients.
The Security and Disaster Recovery Handbook along with the Information Technology Standard
Operating Procedures define overall electronic security policies and procedures for the Statistical Center
resources.
Information Technology network administration staff are responsible for monitoring and addressing
network security and host/server resources, including the database. Network administrators review
network and server event, security and application logs and other reports on a daily basis to monitor
login, file access, security incidents and the status of hardware and services. Notification software is
configured to provide immediate notification (both paging and email) to network administrators for
unexpected network and server events.
Servers and workstations are proactively updated with security patches as well as OS and application
updates. Network administrators subscribe to notification lists to stay on top of emerging problems and
corresponding updates or patches.
All desktop computers, servers and the email post office have active, real-time virus protection. Virus
protection software is automatically pushed to the network and subsequently updated on each system.
Email is scanned for SPAM and virus/spyware. A Web filter is used to protect Internet browsing from
virus/spyware threats.
Computer equipment (including equipment checked out to staff) is logged and tracked in an online
inventory database, including location and use.
Identified real or suspected security incidents are logged, addressed and reported to and/or by network
administrators and the Information Technology Program Director. Problems are in turn reported and/or
escalated as appropriate to SWOG Statistical Center leadership, the SWOG Group Chair’s Office and
Operations Office and/or CRAB Executive Officers.
Senior management, including network administrators, performs risk assessment on new systems and
events to define the cost and benefits of different solutions and the solution impact on confidentiality,
integrity and accessibility.
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Security Assessment
A comprehensive security audit was conducted in May 2005 by an outside consultant, Seitel Leeds &
Associates (SLA). The security assessment was designed to test for and record security vulnerabilities
in selected Statistical Center information systems and to assess specific information security processes.
It included a series of vulnerability tests on all externally accessible Information Systems and internally
accessible systems identified as key systems. It included a review information security processes and
documentation.
The resulting security assessment found several minor vulnerabilities in systems accessible externally
and internally which were readily addressed.
Two significant vulnerabilities were found in two externally directed Web servers with application settings
considered to be high risk, but these were determined not to be a significant threat as they were
mitigated by settings at the firewall. Minor deficiencies found in IT security procedures, primarily
documentation of responses to security incidents, have been resolved. According to SLA’s report,
overall findings were positive and demonstrated that information systems are well secured and managed
and effectively protected from intrusion by unauthorized sources.
In subsequent years, IT processes and systems have been modified and improved to harden security.
Security is an on-going effort at the Statistical Center with emphasis on layered security. Examples of
recent security improvements include recent initiatives to bring systems to the level of security required
for 21 CFR Part 11 and FISMA 2002.
Data Authentication and Encryption
The use of encryption (VPN, SSL and SFTP) reduces the risk of alteration or easily viewing of Internet
traffic (packets) containing sensitive information. Operating system and database controls restrict
inappropriate access privileges to data, files and other objects that require protection from modification.
Currently, Web traffic is monitored and audited at the application level. All data changes are monitored
and recorded in the database audit trail.
Software
The operation of the SWOG Statistical Center depends on five major classes of software: database
management, statistical analysis, desktop applications, network services, and custom-built software for
data collection, data management, and report processing.
Database Management
®
The database management software used is Oracle 10g, one of the major commercially marketed
systems. Oracle is based on the relational model of database management and is built around the
industry-standard SQL language. The Statistical Center's data management operation is built around
Oracle's capability for multiple users to manage simultaneous database modifications.
In addition to the core relational database management module, Oracle has components for ad hoc
queries, report writing, generation of screen-based data maintenance applications, interfacing to high®
®
level languages (C++ or Visual Basic , for example), and database administration and tuning. Quest
Toad for Oracle software tools are used to assist in database management and maintenance.
Database Structure
®
As previously stated, the Statistical Center manages its database using Oracle , a relational database
management system. There is a production database that stores data that are reflective of real events,
a test database that is used for user practice and testing of applications, and a development database
used to design and develop new applications and enhancements to existing applications. Each
database is organized into two schemas, one for staging tables and one for active tables.
Staging tables are used to store submission attempts from electronic data capture applications, attempts
that may violate pre-determined business rules. Once the business rules are fulfilled, data from the
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staging tables are promoted to the active tables. Active tables hold data that are included in evaluations
and analysis.
A comprehensive audit trail records every insert, update, and deletion made to the active tables in
production.
The table structure in the database is organized into the following main components: data to define study
characteristics, patient-related data items common to all Group studies, patient-related data items which
are study-specific, administrative/membership data, and the audit trail.
Statistical Analysis
®
The main statistical package used is SAS 9.1.3. Several in-house programs have been written using
®
SAS and SPLUS 8 to perform tasks such as Cox regression diagnostics, Kaplan-Meier survival curves,
sample size computations, exact methods, recursive partitioning, and longitudinal data analysis.
™
®
Applications used in microarray analysis include R, GenePlus and Insightful S+ArrayAnalyzer .
Desktop Applications
®
Several Microsoft desktop applications are used by staff for day-to-day productivity, including Microsoft
®
Office (Word, Excel, PowerPoint and Access), Visio and Project. Adobe Acrobat and Captivate are
used to create documentation and training animations.
Network Services
Electronic mail is used extensively for communication within the Statistical Center as well as with the
Operations Office, Group Chair’s Office, and other Group members. CRAB and FHCRC staff access
®
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respective Microsoft Exchange post offices with Microsoft Outlook and Outlook Web Access. The
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Statistical Center uses Microsoft Internet Information Server (IIS) for Web services. Teleform is used
for forms design and paper-based data entry. The Statistical Center is currently reviewing document
management systems for processing and tracking controlled documents such as Standard Operating
Procedures.
The SWOG website, found at http://swog.org, is maintained at the Operations Office in San Antonio.
The swog.org website has links to the Statistical Center’s services.
Custom-Built Software
The unique needs of the Cooperative Group environment demand that many of the SWOG’s software
solutions be custom-built. The diverse composition of the membership of the Group, the large number of
users, the volume of studies and patients, and the available budget all present enormous challenges that
commercial software solutions do not meet. SWOG has enjoyed much success in creating software
applications specifically designed for the needs of the Group, and maintaining the necessary control of
those applications to apply enhancements as needed.
All applications created since 2002 are Web-based and are built and maintained in-house using
ASP.NET by the applications development staff at the Statistical Center. The one exception is the
radiologic image transmission software that was written by AG Mednet, a commercial vendor, and is
supported by internal functions to facilitate data capture. Applications Development is governed by a
formal software development life cycle that includes planning, requirements gathering, development,
testing, and a multi-stage deployment process. Details of this process are further discussed under
Quality Control, below.
Data Collection
The SWOG electronic data capture applications are designed to efficiently and securely collect study
data submitted by CRAs. The CRA Workbench website supports the Statistical Center’s primary EDC
applications, including patient enrollment, data submission, specimen tracking, and Web user
administration, as well as applications to support the unique requirements of early therapeutic (Phase I)
studies and the collection of research images.
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Patient Enrollment (WebReg and OPEN)
“WebReg” SWOG’s patient registration and randomization application is a highly flexible, metadatadriven system used to enroll patients on SWOG trials. It is designed to handle the requirements
necessary for the wide variety of SWOG studies, including Phase I-III, multi-step and blinded designs.
Randomization is typically accomplished using a dynamic balancing algorithm, which uses current
accrual counts by stratification variables directly from the database.
Study set-up procedures are based on a comprehensive checklist and standardized scripts, allowing
most study set-up to be completed in an hour or less. WebReg is used by SWOG institutions and
central offices of other Cooperative Groups and CTSU alike, to perform all enrollments to SWOG
therapeutic trials.
Since October, 2009 all new studies have complete enrollments using the Oncology Patient Enrollment
Network (OPEN) application, designed by the CTSU. This is possible through a SWOG-built “rando
node” web service that passes data back and forth between OPEN and the Statistical Center database.
Clinical Data Submission
Submitting data by mail or fax had always been an option for SWOG institutions. Online data
submission was introduced as an option to SWOG members in 2002. In August 2006, SWOG began
requiring member institutions to submit all data online. Online data submission was made available to
non-SWOG institutions in October 2010. The data submission portion of the CRA Workbench website
allows the user to query a list of patients based on helpful parameters. Patients who are followed by the
user’s institution that meet the specified parameters will display for selection. Once selected, the user
sees patient information in an organized tabbed format, and can easily choose to view electronic case
report forms (eCRFs), expectations or queries for that patient.
Entry of eCRFs is intuitive and requires little training. Upon submission, comprehensive edit checks run
immediately, and may return error or warning messages to the user. Partially completed or
unsuccessfully submitted forms are saved for later action, if needed. The baseline abnormalities and
adverse events forms come with helpful lookup tools by the appropriate toxicity criteria in use for the
protocol, by typical events expected for the treatment, and by keywords.
Specimen Tracking
The SWOG Specimen Tracking application is a robust software application built to replace a legacy
paper-based system of tracking specimens. It has been in use since 2003, and currently tracks
specimens for almost 200 SWOG studies. Specimen Tracking allows for access by non-SWOG users,
who can logon using their CTSU username and password. A Web service authenticates these users
against the CTSU database.
CRAs use the application to log specimens and indicate when those specimens have been shipped to
the respective lab or repository. Lab and repository staff use the application to indicate when those
shipments are received, and to indicate if the specimens were derived and/or shipped to another
destination. Each repository maintains its own inventory database using its own custom system. The
Specimen Tracking application is fully metadata-driven; a new study can be set up in an hour or less.
Enhancements to this application continue to be developed.
Web User Administration (WUA) Tool
The management of Web user passwords and permissions has always been a de-centralized activity
within SWOG, and the Web user administration (WUA) application is the primary tool used to manage
these security data. Each member institution has a designated WUA who is responsible for helping their
staff and affiliates with password and access issues for online SWOG applications, and for assuring that
their users are trained in the use of SWOG applications before granting permission to use them.
Early Therapeutics
The Early Therapeutics application includes features that meet the special needs for data collection and
study management required by multi-site, Phase I studies. This application is used by participating
CRAs to submit data, and by Biostatisticians, Data Coordinators, and Study Coordinators to view
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specialized reports focusing on adverse events and potential dose-limiting toxicities. Study Coordinators
and Biostatisticians collaboratively use the application to open and close arms of the study as dose
levels are reviewed and escalated. Since 2002, over 270 patients have been registered and followed on
six studies through this application.
Imaging Network
The Imaging Network enables SWOG institutions to easily, securely and seamlessly send images (e.g.,
MRIs, PETs, CTs, photomicrographs, and X-rays) and associated data to the reference radiologist for a
trial and to a central repository at CRAB.
The Network, which also is open to participants from other Cooperative Groups, enables institutions to
support patient care by allowing “clinical reads” at the institutions of submitted images, while also
providing a “blinded central read” so that SWOG can verify response and progression as read at the
institution.
Data Management
Some of the data management applications, such as the patient evaluation application (EVE) precede
advancements in Web-based technology, and so are thick-client applications built in Visual Basic.
These applications are accessed through the individuals’ Oracle account and password. Others, such
as the electronic chart management application (Chart Manager), are more recent and are therefore
Web-based and built using ASP.NET.
Together, Eve and Chart Manager act as the primary tools for the Data Coordinators to view and
manage electronic research records and enter centrally derived evaluation data regarding eligibility,
treatment and response. The results of the Data Coordinator’s reviews are made available to the Study
Coordinator for confirmation via the Study Coordinator Evaluation application.
Patient Evaluation (Eve)
The patient evaluation application allows Data Coordinators to enter derived data pertaining to eligibility,
treatment, and response with comprehensive cross-field edit checks. The Data Coordinator also uses
Eve to write data queries, manage expectations, and indicate which cases are ready for Study
Coordinator review.
Chart Manager
All patient data are organized into electronic patient charts through the Chart Manager application. Data
Coordinators, Biostatisticians and Study Coordinators all use this application to view patient charts
online. Data Coordinators have access to tools to sort, redact, annotate, and print charts as necessary.
All research records received online or on paper are converted to TIFF images and are stored and
managed in this application.
Study Coordinator Evaluation
The Study Coordinator evaluation application allows Study Coordinators to view the electronic charts
online through a link to Chart Manager, and complete their evaluation forms to agree or disagree with
assessments made by the Data Coordinator. The user navigates the application through helpful lists of
patients with outstanding evaluation forms. Monthly emails are sent to both the Study Coordinators and
Data Coordinators informing them of which patients need evaluations completed, and which evaluation
forms are done.
Data Reporting
The Statistical Center twice yearly Report of Studies (ROS) is created using the Statistician’s Report
®
Worksheet (SRW), an application which incorporates a Web-based interface, creation of a SAS data
®
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set from Oracle , and the word processing tools of Microsoft Word.
Web pages are driven from two primary database sources: Oracle and SAS data sets. MS Internet
Explorer provides a program interface for input of textual and study parameters needed to define and set
up charts, tables, graphs, and descriptive information. SAS extracts the data from the patient database
via Open Database Connectivity to create a SAS data set, i.e., a "snapshot" of the patient data, which is
then archived. Study chapter generation is done on a Web server and is based on input from the SAS
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data sets, study information defined in the Oracle database, and end user input. Examples of user input
are label definitions, table format information, and text (such as the following: objectives, patient
population, accrual goals and study summaries).
Access to the SRW application is limited to authenticated users on the network and it is not accessible
via the Internet. Firewalls are used to audit and restrict access.
Membership Management
A menu of Web-based forms is available to the Operations Office and the Group Chair’s Office to make
database changes for SWOG members, institutions, labs, studies, IRBs, publications, SAEs, audits,
group meetings, and other key areas handled by those offices.
Data Operations
Patient Registration
All patients are registered and, when appropriate, randomized using an online Web registration
application (either WebReg or OPEN), which interacts with the database during the registration.
Approximately 90% of registrations are performed directly by institutional Clinical Research Associates
(CRAs), other Cooperative Groups, or the Cancer Trials Support Unit (CTSU). Intergroup registrations
not coordinated by CTSU require a telephone call to the Statistical Center. Manual registration
procedures are available for the rare event that the online application is unavailable. Registration
procedures are strictly enforced in a uniform manner for all registrations.
WebReg and OPEN check a number of different conditions before allowing a patient to be registered to
a study, including a current FDA-1572 form for the treating investigator and IRB approval for the treating
institution, both downloaded from the CTSU. WebReg can handle a wide variety of study designs with
no additional programming effort. These include studies with multiple registration steps, with blinded
treatment assignments, with a variety of drug distribution processes, and with dynamic balancing of
stratification factors when applicable for randomization.
Flow and Entry of Data
During the last five years, the Statistical Center has implemented significant changes in the way data are
submitted by SWOG members. In 2003, online data submission was very new, and was only one of
three data submission options available, in addition to mail or fax. In August 2006, online data
submission became the only method for SWOG members, for all but selected data (e.g., operative and
pathology reports and patient-completed instruments).
Online submission is required for all studies activated May 2003 and later, but most data for studies
activated prior to that date are also submitted online.
Extensive single-field, cross-field, and cross-form edit checks are incorporated into each electronic case
report form (eCRF). Data submitted electronically require no internal processing prior to evaluation.
Up until October 2010, the option of submitting data online was not available to non-SWOG institutions
participating on SWOG-coordinated trials. Non-SWOG data represent approximately 30% of all
®
incoming data. CRFs submitted by mail or fax are created using the commercial product Teleform ,
which produces CRFs that can be scanned and use an optical character recognition (OCR) to aid data
entry. Although most data for non-SWOG institutions are still collected by mail or fax, the option for
online data submission is new and we anticipate it to be the only option for all data collection by June,
®
2011. In the future, studies that use the Medidata Rave software for electronic data capture will also be
able to collect all data online from all users.
Fax or mail submissions (including source documentation such as operative and pathology reports) are
®
processed by Data Control Technicians using the Teleform software. Data are stored in the database,
and a TIFF image of most forms is automatically sent to the electronic patient chart. Details of these
procedures are described in the Statistical Center’s Data Operations Procedure Manual.
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Evaluation of Data
Upon completion of data processing, the Data Coordinator is responsible for quality control review and
evaluation of eligibility, treatment compliance, disease response and adverse events. Details of these
procedures are described in the Quality Control section, below.
Electronic File Organization
The electronic chart application (Chart Manager) organizes incoming data so that all clinical data for a
patient are located in one electronic file. Chart Manager automatically stores data by SWOG patient
number. Newly submitted data are displayed separately from data which have been reviewed. Data
Coordinators have full flexibility to organize the electronic charts with the most recent data at the top and
may employ annotation and redaction tools for Protected Health Information, as necessary. Electronic
records are saved in a back-up database each evening (see disaster recovery under Computing
Infrastructure, above).
Data Operations Communications with SWOG Institutions
There are a number of procedures in place to facilitate communications with Clinical Research
Associates (CRAs) and physician members at SWOG institutions. CRAs have long enjoyed access to
online tools for SWOG patient management through a single website called the CRA Workbench. The
CRA Committee relies on the workbench to promote further training and post “tools of the trade” and
reports specific to SWOG. Among these reports are the monthly Institutional Performance and
Expectation Reports, and Query Reports, described under Quality Control, below.
In addition to electronic communications via the CRA Workbench, Data Operations staff offer assistance
for troubleshooting questions about protocol and data management via email and/or telephone
(approximately 20 per week for each Data Coordinator).
Quality Control
(see Group policy #18, http://swog.org/Visitors/download/policies/policy18.pdf)
Quality control occurs on every level including the development and scientific review of new protocols,
the functions of the Data Operations department, reporting, training, interactions with other Cooperative
Groups, creation and analysis of final data files and practices and procedures within the Statistical
Center’s computing infrastructure. Each of these is described below with the exception of Quality
Assurance activities of the Group, which are coordinated by the Operations Office.
Protocol Development Process
The first step to ensure quality control in clinical trials is to develop protocols that are clearly stated and
exhaustively inclusive of all criteria and procedures necessary for conduct of the study. The protocols
are one standard against which the Group measures the conformance of the investigators. Most
importantly, protocols reflect the scientific direction and standards of the Group.
Statistical Center staff members are integral to the collaborative team charged with the development of
new SWOG trials. Committee Biostatisticians work closely with the Study Coordinator and other
members of the study team to ensure that the scientific goals of the trial are precisely defined, and that
the study is designed to maximize the ability to meet these goals. To this end, protocol development
follows a series of steps, with those portions that involve Statistical Center staff input described below.
Additional details of the protocol development process are available from the Operations Office which
coordinates the protocol development process.
Study Capsule
Ideas generated by Group members for new studies are typically presented to the committee chair and
membership either by email, conference calls or twice yearly meetings. Those ideas that are considered
of potential interest are developed into a “capsule” by the proposed Study Coordinator. At this early
step, initial conferences with the committee Biostatistician are begun to discuss appropriate study design
options, proposed endpoints, accrual estimates (and hence feasibility), preliminary statistical plans and
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proposed sample sizes. Preliminary discussions of eligibility, potential translational questions, and
details of treatment are also considered at this time. Once the Study Coordinator, appropriate other
investigators and the study Biostatistician complete the capsule, it is first reviewed by a team of
independent statisticians. After approval by the disease committee chair, the capsule is then submitted
for discussion during the SWOG Executive Committee weekly conference call.
Executive Committee Approval
The Group Biostatistician and Deputy Director are members of the Executive Committee, along with the
Group Chair, Executive Officers, Chief of Administration, and Operations Office Manager. This group
reviews capsules for scientific soundness, feasibility, appropriateness to the Group mission, priority, and
resources. Studies that are approved are then either directed for immediate development, or sent on for
Cancer Therapy Evaluation Program (CTEP) or Division of Cancer Prevention (DCP) approval prior to
development.
Protocol Development
Committee Biostatisticians work closely with the Study Coordinator and Protocol Coordinator in the
development of the protocol document. While the initial draft is being developed, the Biostatistician
refines the statistical section of the protocol following guidelines established in the Statistical Center’s
Design and Analysis Guidelines document. Early protocol drafts are typically circulated between the
primary Study Coordinator, the Biostatisticians, and other study team members as appropriate.
Statistical Center staff primarily focus on study aims (to ensure that the goals are clearly stated, can be
supported by the design, and that appropriate data are collected to meet these goals), eligibility,
endpoint definitions, statistical design and analysis, and data collection. Although the initial protocol
review at the Statistical Center is primarily the role of the Biostatistician, later drafts include review by the
Data Coordinator, who may provide critiques and recommendations to eliminate ambiguities. Because
the Data Coordinators are the primary recipient of questions from institutions, their experience in
identifying sources of confusion and lack of clarity is invaluable in the development process, so as to
minimize the potential for amendments after study activation.
During this development time, the study Biostatistician, Data Coordinator and Forms Developer draft
data collection forms based on established Group templates. For Phase III trials, drafts of these forms
are submitted for Common Data Element (CDE) review and modified as needed. Please see a
description of this process below.
Protocol Review Committee
Once a protocol document has been reviewed by the study team, it undergoes a consistency check at
the Operations Office, where it is reviewed for compliance with standard wording. The protocol is then
submitted to the Protocol Review Committee (PRC) at the Statistical Center. This committee is chaired
by the Deputy Director, and consists of one other faculty Biostatistician and 3 to 4 M.S. Biostatisticians
who serve on a rotating basis. A subset of this committee is assigned to review individual protocols, with
the goal of having a set of independent reviewers for the study. The Statistical Center has found that
this review helps identify issues that may have been overlooked by the Biostatisticians who are more
directly involved in the protocol. Moreover, this review ensures consistency of approach across studies
(where appropriate).
The PRC meets weekly as needed; committee members receive a copy of the protocol, comments from
the study Biostatistician, draft data collection forms, and a copy of the NCI Protocol Submission
Worksheet. The study Biostatistician(s) and Data Coordinator attend, and the Director of Operations and
Protocols as well as the Protocol Coordinator from the Operations Office attend via conference call.
Study Coordinators may also participate as scheduling permits. Each section of the protocol is
discussed, and the study Biostatistician compiles a list of questions and comments from the reviewers.
Items requiring Study Coordinator input are then forwarded for final discussion and study modification,
as needed.
Protocol Approval Process
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Once a protocol completes this internal review process, it is sent to CTEP or DCP for review. In some
cases the national review may also involve the Central Institutional Review Board (CIRB), a
pharmaceutical review, or FDA review, as appropriate. Biostatisticians reply, as needed, to any
comments resulting from this review, and may participate in conference calls as needed to resolve
issues related to the protocol.
Protocol Activation Process
Once a protocol has been approved for activation, the committee Biostatistician and Data Coordinator
develop the study description checklist, a document that defines how the study will be programmed in
the database. This comprehensive checklist identifies all study characteristics stored in the SWOG
database, and includes descriptors about the study as well as treatment arms and assignment, discipline
review, stratification factors, expectations, and required or optional ancillary studies, as appropriate.
Because many of these variables affect the way the online patient registration, randomization (if
applicable), and specimen tracking applications will operate, these applications are tested by the
Biostatistician and Data Coordinator prior to activation and reviewed by an independent Biostatistician.
The Biostatistician and Data Coordinator also test the case report forms to be sure that they are
accurately represented online.
Proposals/Protocols for Translational Research Projects
Translational research projects may be embedded in a therapeutic protocol as an integral part of the
study, or may arise as a separate proposal based on banked specimens. In the case of the embedded
protocol, approval of the therapeutic study constitutes approval of the translational study. In the latter
case, a separate proposal is submitted. Development of this proposal models protocol development, in
that a “capsule” is developed by the translational researcher in collaboration with the disease committee
Biostatistician. The Biostatistician helps to ensure that the proposal includes clearly specified aims, a
statistical design, and a summary of the number of available specimens in the bank with corresponding
assessment of power. Translational research proposals must be approved by the appropriate disease
committee, the translational subcommittee and the disease chair, before being submitted to the SWOG
Executive Committee for review. Studies involving more than 100 specimens or from Phase III trials
must also be submitted to the NCI (either to a disease specific steering committee or banking committee)
for approval.
For studies that involve translational research questions that are not an embedded part of the
therapeutic protocol, separate funding (e.g., an R01) may be required to support the project. The
committee Biostatistician will collaborate with the translational research team in the development of the
grant submission, which includes requests for funding for the statistical support necessary to fund the
research. Examples of such successful submissions include SWOG lung study S0003 and the study of
markers of hypoxia (Dr. Philip Mack, PI) and SWOG breast study S0221 and the use of anti-oxidant
supplements (Dr. Christine Ambrosone, PI).
Functions of the Data Operations Department
Eligibility and Initial Treatment Review
(see Group policy #18, http://swog.org/Visitors/download/policies/policy18.pdf)
Initial forms required to document prestudy (baseline) requirements and treatment initiation are reviewed
by the Data Coordinator to ensure protocol compliance. This review confirms eligibility, assures that
prestudy information pertaining to stratification variables is consistent with that given at registration, that
body surface area is calculated correctly, that required baseline procedures were performed within the
defined time interval(s), and that initial treatment was given as per the protocol.
Patient Evaluations
All patient charts are evaluated by the Data Coordinator at specific key timepoints: the eligibility and
initial treatment review, serious adverse events, progression, off treatment, death and other pre-specified
times (e.g., response). Data Coordinator evaluation involves a comprehensive review of submitted data,
posting queries when necessary, and coding and entering derived evaluation variables which summarize
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eligibility, disease status, treatment parameters, major protocol deviations, and response. Results of the
Data Coordinator’s evaluation are considered preliminary and are provided to the Study Coordinator for
confirmation and further evaluation via the online Study Coordinator Evaluation application. Through this
process, if a disagreement results and cannot be resolved between the Data Coordinator and the Study
Coordinator themselves, the disease committee Biostatistician is consulted. Continuing disagreements
are rare, but can be adjudicated by the disease committee chair or, if necessary, the disease site
Executive Officer or Group Chair.
Queries
If a documentation error or discrepancy is noted at any timepoint during the evaluation process, the
results are communicated to the registering institution via queries written by the Data Coordinator.
Queries for outstanding or amended data are available to the Clinical Research Associate (CRA) on the
CRA Workbench website. The institution may correct the error by submitting the appropriate amended
form and the query will be resolved upon receipt and satisfactory review.
Data Coordinator Training Program
The Statistical Center has developed and follows a rigorous training program for its Data Coordinator
staff. The Data Coordinator Training curriculum includes Standard Operations Procedures and Data
Operations Procedure Manual and is tailored to each Data Coordinator’s incoming knowledge level.
While in training, 100% of the Data Coordinator’s data evaluations are carefully monitored. This process
ensures the quality of data evaluations during the DC’s training period and establishes a firm footing for
continued success.
Data Coordinator Quality Assurance
The Data Coordinator Quality Assurance program, a supplement to the Statistical Center’s more rigorous
Data Coordinator training program, is an internal audit mechanism designed to monitor and maintain the
quality of data evaluations conducted by Data Coordinators after they have completed training. Each
Data Coordinator is audited twice per year by the Quality Assurance Coordinator, a seasoned Data
Coordinator with over 25 years of experience. At each twice yearly audit, ten subject records for each
Data Coordinator are reviewed. Areas of emphasis include coding of eligibility, disease status,
treatment, reason off treatment, adverse event, and evaluation notes. Detailed feedback is provided to
the Data Coordinator and his/her supervisor. If necessary, further instruction and education are provided
to the Data Coordinator to ensure that errors are not repeated.
Administrative Committees
The Statistical Center provides support to three SWOG active administrative committees: radiation
therapy, pathology and surgery.
The review functions performed by the administrative committees are designed to answer questions of
protocol eligibility (pathology and surgery) or protocol compliance (surgery and radiation therapy). In
addition, the review processes yield important detailed data regarding pre-treatment status (pathology),
procedures performed (surgery and radiation therapy), or outcome (pathology and surgery).
Statistical Center operations that support administrative committee functions include the following:
1. A staff Biostatistician is assigned as the statistical liaison to each administrative committee. This
Biostatistician is responsible for assuring that the review processing requirements of the
assigned committee are implemented and functioning properly, and for seeing that the
committee is provided the necessary information to support its operations.
2. Data Coordinators assist the administrative committees by providing various services as
needed. These include quality control of discipline forms, review of protocols with respect to
administrative committee data processing, and enforcement of protocol requirements.
3. The patient registration application contains specifications to support the various discipline
review requirements. Most of these are processing steps to be executed at the time of patient
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registration and others cause appropriate flags to be set in the database. The processing steps
include items such as requests for additional discipline-specific information, display of special
notes, creation of expectations, and validation of special eligibility requirements. The database
flags include indications that the patient is registered to a study involving one or more review
processes, and the setting of these flags may depend on the treatment assigned.
4. The expectation system is used to notify institutions of the need to submit materials required for
the review processes, and then to track the submission of the materials; it also yields timeliness
data for these submissions.
5. The central review process produces specific summary results of items pertaining to a)
pathology or surgery eligibility or, b) surgical or radiation therapy protocol compliance. These
summary data are entered after the review is completed.
6. Reports are prepared by the Biostatisticians for administrative committee and Group leadership,
on an as needed basis. These reports can include review results, number of reviews performed,
number of overdue reviews, and other summary statistics.
Radiation Therapy (RT)
Rapid review of radiation therapy for SWOG studies is managed by the Quality Assurance Review
Center (QARC) in Providence, Rhode Island. One Biostatistician is assigned oversight to this
administrative committee. The RT Biostatistician notifies QARC of each new registration to a study that
included RT review, and QARC is responsible for notifying institutions of the need to submit materials
and/or forms required by the review process.
On-study (“rapid”) RT reviews are performed by radiation oncologists and dosimetrists at QARC, while
end-of-study RT reviews are performed by the SWOG radiation oncologist designated as the RT Study
Coordinator for a specific study. The RT Study Coordinator travels to QARC to perform the reviews in
one or more batch review sessions, and QARC maintains the review results. The summary data are
sent to the Statistical Center on a quarterly basis, or other specified schedule for individual protocols.
QARC prepares reports for the Group meeting, including information on the number of reviews
performed for specific protocols.
Study Coordinator Evaluation Monitoring
The Data Coordinator will flag a case for Study Coordinator review at certain key timepoints after patient
registration to a SWOG protocol, e.g., after a serious adverse event occurs, following completion of
treatment, at relapse, and at death if not previously evaluated at relapse. For some protocols, it may be
appropriate for the Study Coordinator to evaluate patient data every three months or more often during
treatment. Study Coordinators are expected to review coding of eligibility, stratification, treatment,
adverse events, clinical outcome, study endpoints, and evaluation notes.
An automatic monthly email, generated by the database, is sent to the Study Coordinator and lists which
cases on their studies require review. A similar email is sent to the study Data Coordinator, listing which
cases the Study Coordinator has reviewed.
Study Coordinators access the review forms and patient charts using the online Study Coordinator
Evaluation application. All Study Coordinator evaluations are tracked for completion and timeliness.
After submission of each evaluation form, any coding changes made by the Study Coordinator are
reviewed and entered into the database by the Data Coordinator. See the Computing Infrastructure
section, above, for more information about this software application.
Expectation System
The Statistical Center expectation system provides the structure within which data submission
requirements are implemented and measured. The primary focus is data submission timeliness. The
expectation report notifies CRAs when specific data or tasks are coming due, or are overdue.
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Expectations define timeliness data for each institution, per protocol and are summarized in a monthly
Institutional Performance Review (IPR) report. A static, monthly snapshot of expectations is provided on
the CRA Workbench to help CRAs prioritize data collection most important to each SWOG study. In
addition, a CRA may use an interactive, real-time expectation report which reflects the current overdue
data.
Expectations are defined as part of the study set-up and are posted automatically at the conclusion of
the registration process. Expectations are highly study-dependent and may depend on patient- or
registration-specific factors including demographics, treatment assigned, applicable stratum, registering
institution, prior treatment, and/or prior pathology reviews.
Expectations are resolved when the SWOG Statistical Center receives the data or is provided evidence
that the task has been performed. In almost all cases, expectation resolutions are automatic upon data
®
entry of the expected form either online or via Teleform . Specimen submission expectations are
resolved when the expected specimen is indicated as shipped in the Specimen Tracking application.
Expectations may also be manually added or resolved by the Data Coordinator as necessary.
Reporting
Institutional Performance Review (IPR)
In conjunction with the monthly expectation report, the Statistical Center summarizes monthly statistics
to assess institutional performance with respect to data submission. These standards, described in
SWOG Policy #33 (available at http://swog.org/Visitors/Download/Policies/policy33.pdf), assess
timeliness of data submission in three categories: initial forms sets, follow-up for patients still on protocol
treatment, and follow-up of patients who are no longer on protocol treatment.
Data items that are overdue in any of these categories are starred on the institution’s expectation reports
to aid in identification of cases requiring immediate attention. The monthly IPR statistics are reported to
the institutions and monitored at the Statistical Center by the Deputy Director. Institutions that are out of
compliance for two months in a row receive a warning letter. Any institution that is out of compliance
with the standards of the Group for three months in a row are subject to suspension of registration
privileges until the deficiencies are corrected.
In the year prior to mandatory online data submission and to the distribution of IPR and expectation
reports via email to the Study Coordinator and head CRA, 63 warning letters were written and 1
institution was suspended. In the year following these changes, 30 warning letters were written (a 53%
reduction), and no institutions were suspended.
Serious Adverse Event (SAE) Reporting
Serious adverse events are reported in several ways. If an SAE occurs that is reportable per protocol,
investigators are expected to report it immediately via a telephone call to the Operations Office and/or by
entering it into the NCI’s Adverse Event Expedited Reporting System (AdEERS). Certain adverse
events, including fatal toxicities for all treatments and life threatening non-hematologic toxicities for
investigational treatments, automatically qualify as SAEs across all studies.
Toxicities for treatment studies are entered into the SWOG database via adverse event forms submitted
by institutions.
If a grade 5 (fatal) toxicity occurring within 30 days of last protocol treatment is entered for any patient, or
if a grade 4 (life threatening), non-hematologic toxicity is entered for patients receiving investigational
treatment, and the event has not been reported as an SAE, the Statistical Center SAE Coordinator and
the Operations Office SAE Program Manager are notified by a weekly automatic report. The SAE
Program Manager then contacts the institution to request that the event be reported into AdEERS.
Serious adverse events reported to the Operations Office through any of the above methods are entered
into the SAE tracking system by the SAE Program Manager. An automatic email alert is sent to the
Study Coordinator and study Biostatistician. The SAE is further reviewed by the Operations Office to
confirm its attributability to protocol treatment, and institutions are consulted as necessary during this
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process. Once the SAE has been reviewed by the SAE Program Manager, a copy of the AdEERS report
and any source documentation received from the institution is forwarded to the Statistical Center to be
scanned into the electronic chart. The entire chart is then updated and reviewed by the Data
Coordinator before generating an evaluation form for the Study Coordinator for final review of the SAE.
In 2008, the Statistical Center collaborated with the Serious Adverse Events Programs Manager at the
Operations Office to facilitate enhancements to SAE data storage procedures. Data for SAEs reported
on or after November 1, 2008 are converted to electronic images and delivered to the Statistical Center
and stored in Chart Manager. This includes any supporting source documentation, which previously had
been filed as paper at the Operations Office and was not part of the patient’s electronic data record at
the Statistical Center.
A report is posted to the CRA Workbench for use by CRAs to generate SAE listings for IRB review.
Clinical Data Update System (CDUS) Reporting
The Statistical Center submits quarterly reporting to the Clinical Data Update System (CDUS) as
required by the National Cancer Institute (NCI). There are currently approximately 15 studies requiring
Complete Reporting and 97 with Abbreviated Reporting. Once the quarterly report is submitted, an
extensive reconciliation process occurs. In addition, CTEP sends a report at the start of the quarterly
report cycle containing all SAEs for pertinent studies that were reported since the end of the prior
quarter. It is the Statistical Center’s responsibility to make sure each grade 5 SAE included in the report
has a match in the CDUS submission file. If there is a mismatch, data tables and email are compared to
the AdEERS notification system for the problem patient number. Data Coordinators and the SAE
Program Manager at the Operations Office are then notified and requested to follow up and reconcile the
situation prior to submission.
At times the institution will file an AdEERS report that disagrees with the submission SWOG sends to
CTEP via the CDUS. Starting in 2007, CTEP requires that any grade 5 adverse event SWOG reports
must have a match to the site’s AdEERS report. The matching criteria are patient number, cycle
number, adverse event, grade and attribution. If any of these criteria do not match, the data submission
is rejected.
Report of Studies
All open and recently closed studies are reported twice yearly in conjunction with the Group Meetings.
The Report of Studies is described in more detail under Data Reporting and Analyses.
Other Reports
In addition to reporting described above there are numerous reports available to our institutions on the
CRA Workbench and the Group submits reports as required to the NCI.
Training Programs
Clinical Trials Training Course (CTTC)
The training course provides an overview of SWOG as well as information pertaining to topics such as
the explanation of clinical trials, phases of studies, quality control, quality assurance, ethics and quality of
life. Familiarization with the SWOG registration process, forms, and office procedures is also included.
A practicum round-table discussion provides clinical research associates with practice of forms
completion, adverse event grading, response assessments, and calculating laboratory values.
An explanation of data flow, the expectation system, patient follow-up, and adverse events are other
topics discussed in the training. The Clinical Research Manual (CRA Manual), which details the
administrative procedures of the Group and the forms and coding guidelines of each disease committee,
is available via the internet at swog.org. CTTC participants are oriented to the web-based manual during
the training course. Approximately 90 participants attend the training course offered during each Spring
Group meeting.
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®
In October 2010, the CTTC was made available as an online course using Adobe Captivate software.
The intent is to provide immediate training to new CRAs to the Group as well as provide a refresher to
more experienced members.
Specimen Tracking
Online training is available to describe the use of the Specimen Tracking system.
Study Coordinator Workshop
Members of the Statistical Center staff, in conjunction with Operations Office staff have designed an online training course for physician investigators who have never served as a SWOG national Study
Coordinator and who wish to coordinate a Group protocol. The workshop's primary objective is to
provide the foundation necessary to perform the responsibilities of a SWOG Study Coordinator. The
course is located on the Study Coordinator workbench on the SWOG website. Participants must
complete the full course, as evidenced by completion of the test questions at the end of all presentations,
to receive approval to develop and coordinate a SWOG research trial.
The course provides training in the responsibilities of a Study Coordinator, and of the coordinated efforts
of the Statistical Center and Operations Office. There are presentations on ethics, protocol
development, clinical trials design, the evaluation process and Study Coordinator responsibilities during
development, during study accrual and during manuscript preparation.
Young Investigators Training Course
The Young Investigators Training Course is an intensive 3-day workshop held annually to develop a
cadre of experts able to quickly and efficiently develop priority studies. For the purposes of this training,
young investigators are defined as oncology fellows in training or assistant professor equivalents
affiliated with Group institutions or otherwise eligible for Group membership. The course primarily
focuses on protocol development, maintenance, and administration.
These young investigators are asked to produce a concept for a SWOG Phase II or Phase III protocol
and follow this idea through an intensive simulation of the protocol development process. A panel
including Group leadership and the Chair of the applicable Disease Committee reviews each application
package and chooses attendees for each training course. At the end of the course, the investigators'
ideas are presented to the respective disease committee chairs for consideration of activation within the
Group. While no guarantee is given that these particular ideas will be pursued within the Group, it is
hoped that the principles learned through this workshop will produce attractive protocols that will be of
great interest within the committees.
Interactions with Other Cooperative Groups
SWOG participates in NCI-sponsored intergroup protocols. These are protocols in which more than one
Cooperative Group participates. The protocol is coordinated by only one of these groups. The two types
of coordination are as follows.
SWOG Coordinated Trials
SWOG currently coordinates 26 open intergroup treatment protocols. These studies are available to
non-SWOG participants either via the CTSU menu, or directly with specific Cooperative Groups as
traditional intergroup studies. For all of these protocols, a number of special procedures exist.
1.
The online registration system can accommodate registrations from non-SWOG institutions
either from the CTSU or the participating group’s central office.
2.
The database stores identifying information pertaining to the participating group investigator and
institution associated with each patient to support requests for queries or follow-up data sent to
other statistical centers.
3.
Since early 2008, the Statistical Center has been given responsibility for complete data
collection and tracking of information from institutions registering through the CTSU to SWOG-
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coordinated trials. The expectation reports, queries and requests for follow-up are either
emailed or faxed to the CTSU-designated individual at each institution.
4.
For traditional intergroup studies, expectations and queries are forwarded to the participating
group’s central office.
5.
Procedures are in place to allow participation with collaborators outside of the United States.
Other Group-Coordinated Trials
SWOG participates in treatment trials coordinated by other groups. These trials can be run either
through the CTSU and are endorsed by SWOG, or can be run via the “traditional intergroup” mechanism.
The primary difference to SWOG is that registrations to traditional intergroup studies go through the
Statistical Center, whereas registrations to CTSU trials endorsed by SWOG do not. Accruals to the latter
trials are downloaded from the CTSU into the SWOG database.
In either case, data from the SWOG institution are sent directly to the Coordinating Group. A weekly
database transfer from the Coordinating Group to SWOG updates the patient’s survival and last contact
information so that the institution follow-up payment can be handled appropriately.
During the period 2006 to present, the Group participated in 58 trials coordinated by other Cooperative
Groups. The Statistical Center’s responsibilities for all of these trials include cooperating with the
Coordinating Group’s central office by performing data monitoring and follow-up tasks as required.
Creation and Analysis of Final Data Files
After assuring quality data are collected and evaluated during the trial, quality control remains important
TM
in the analysis of data. Statistical analyses within SWOG are primarily conducted using SAS .
Analysis data files, which include patient characteristics, eligibility, treatment and response variables, are
created in the Statistician’s Report Worksheet (SRW) application. These variables are uniformly named
and defined across studies. Additional study or disease-specific variables may be merged into existing
TM
data sets as needed using SAS . Data sets and final annotated analysis programs are archived in a
central directory once an abstract or manuscript is accepted for publication.
Computing Infrastructure Quality Control
To ensure effective and efficient quality control for the development and maintenance of hardware and
software applications, the SWOG Statistical Center closely follows internal Standard Operating
Procedures.
Information Technology
Information Technology standard operating procedures were derived from a combination of industry
“best practices” for network data security, disaster recovery, systems configuration, and operational
business requirements. Systems requiring regulatory compliance follow additional standards under the
Federal Information Security Management Act (FISMA) of 2002 as defined by the National Institute of
Standards and Technology (NIST) and 21 CFR Part 11 guidelines as outlined by the Food and Drug
Administration.
Systems are carefully designed to meet application and user requirements and are deployed following
standardized work instructions. Once in production, systems and services are monitored in real-time by
a variety of software tools to verify that performance and functional expectations are being met. Detailed
monitoring also ensures that problems are detected in their infancy, thereby facilitating rapid resolution.
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Applications Development Quality Control
Software Development
The Statistical Center creates software applications in a controlled development environment guided by
standard operating procedures that cover best practices for coding standards, naming conventions,
formal code reviews, formal change request processes, and documented testing and bug
reporting/tracking systems. As required, the Statistical Center has processes and procedures in place to
create applications that fully comply with Food and Drug Administration requirements under 21 CFR Part
11. These applications are housed on fully compliant hardware, including qualified servers for
development, testing and production.
The software development life cycle (SDLC) begins with requirements gathering. The Program Manager
will meet with applicable stakeholders to design the desired application or enhancements, and write a
Functional Specification document for the developers and testers. The Functional Specifications include
both page mock-ups and verbal explanations of expected user input, and page navigation. Technical
details, such as relation to existing table structure, are also included, as necessary for coding.
Development of the software follows documented coding standards, and may include formal code
reviews as necessary. Developers perform unit testing as code is developed, and work closely with the
Program Manager to resolve feature issues as they arise. Any major database architecting needs are
addressed by a team of senior developers.
When a test candidate is ready for release, the application will be published to the test environment for
testing by the Applications Development Quality Assurance team. Testers will use the Functional
Specifications as a representation of expected behavior, and will attempt multiple paths of navigation
and input to find potential bugs in the software.
After all undesirable bugs have been resolved, and any necessary regression testing is complete,
representative stakeholders perform user acceptance testing (UAT) in the test environment. The
stakeholders work with the Program Manager to decide which, if any, additional changes will be
incorporated prior to release. If changes are introduced, testing and regression will be re-performed as
necessary.
®
The Applications Development staff use Microsoft Team Foundation Server (TFS) for their development
environment. TFS provides developers with a powerful suite of tools for managing and maintaining
code. The source control functionality of TFS is strongly integrated with the development environment.
This allows developers to seamlessly track changes in code, branch and shelve code, view code
histories and automate builds. TFS is particularly useful for tracking work items such as functional
specifications, change requests, and bugs. Work items may be linked to written code which aids
documentation and publishing. TFS provides useful reports for project tracking, and keeps a
comprehensive audit trail of all documentation and work item changes.
When this process is applied to applications which are being built to be compliant with 21 CFR Part 11,
the following artifacts are created to document each step of the SDLC:
1. Business Requirements
2. Project Plan
3. Functional Specifications
4. Hazard Analysis
5. Technical Specifications
6. Code Review Plan
7. Build Notes
8. Developer Testing
9. User Testing Protocol
10. User Testing Report
11. Installation Protocol
12. Installation Report
13. Release Notes
14. System Release Report
15. Validation Completion Report
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Traceability is present throughout many of these documents. Business requirements are traced to
functional specifications, and functional specifications are traced to hazards, test cases, and test results.
These links help provide solid documentation that the application performs as expected. This traceability
is also present in TFS as the work items are documented and tested.
The decision to build an application in a validated manner is based on the requirements for the
application. Validated applications must exist on qualified servers, and interact with a qualified
database. Because much of SWOG’s legacy infrastructure precedes 21 CFR Part 11, most of the
security and membership data needed to support the applications exist on non-qualified hardware, and
were entered using non-validated software. It is for this reason that validation is currently only pursued
in environments which can be handled separately from the legacy infrastructure. However, even when a
formal validation effort is not appropriate, the Applications Development staff apply many of the same
principles, to deploy quality, bug-free software applications.
Case Report Form Development
Case report form (CRF) creation starts with the design of the form. Some standard, Common Data
Element (CDE)-compliant CRFs are available for use across all studies, such as the Baseline Tumor
Assessment form, Follow-up Tumor Assessment form, Off Treatment Notice, Follow-up form and Notice
of Death. For other necessary study-specific CRFs (e.g., Prestudy, Treatment, Adverse Events), the
Biostatistician for the study collects comments from all members of the study team, and works with the
Forms Developer to come up with a final design for each one. The Biostatistician and Data Coordinator
also complete an Edit Check Worksheet for each study-specific CRF. The worksheet assumes a
standard set of edit checks, but allows the user to make exceptions and additions to these as needed.
Because the same Forms Developer designs all CRFs, consistency in design can be easily controlled
across studies.
Once the CRF design is final, the Forms Developer can quickly prepare the HTML and enter edit check
logic into a code generator which completes the form. After development, all CRFs are subject to testing
within the Applications Development department and to UAT by the Biostatistician and Data Coordinator.
The form is then released to production on or before the activation date for the protocol. This process
has been recently standardized and streamlined. A lead time of one month prior to activation is
requested to perform all development and testing tasks for new study CRFs.
To set up a new study in OPEN, the Forms Developer will submit the appropriate Registration
Worksheets for Common Data Element (CDE) review, and inclusion into the Cancer Data Standards
Repository (caDSR). After the Worksheet is loaded into the OPEN system, the Forms Developer will
use that interface to complete the layout and edit checks within OPEN.
The Forms Developer is also responsible for entry of study metadata into the database. The
Biostatistician and Data Coordinator complete a detailed study description checklist (described above) to
describe a wide variety of study characteristics. All of these study attributes are critical for applications
such as OPEN and Specimen Tracking to operate accurately. After entry, the Biostatistician and Data
Coordinator test the affected software applications to be sure they run as expected. Entry of the study
metadata usually takes less than one hour.
It has been a great help to channel the CRF development and study set-up process through the same
staff member. The Forms Developer can compare the study attributes to the form design and question
any perceived inconsistencies, particularly in the use of cycles and expectations. This is a valuable
service to Biostatisticians and Data Coordinators, and allows for an objective and consistent point of
view across all studies. The Forms Developer has a primary back-up within Applications Development
who is periodically assigned a new study, to keep current on the procedures. These two can also be
assisted by other developers as necessary.
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Statistical Designs and Study Monitoring Policy
(see Group policy #21, http://swog.org/Visitors/download/policies/policy21.pdf)
Phase I Trials
Phase I studies are monitored intensely by the study team through the Early Therapeutics system and
weekly teleconferences. Opening and closing of cohorts requires the active agreement of the Study
Coordinator and study Biostatistician.
Phase II Trials
Single Arm Trials
Historically, the standard SWOG approach to investigational new agent Phase II designs was based on
a single arm test of the null hypothesis that the response (or other outcome) probability is pO, too low to
be of interest, vs. the alternative that is pA, sufficiently high to warrant further study, at a one-sided level
approximately .05 and power close to .9.
These Phase II studies are generally designed with two-stage stopping rules, and protocols are
temporarily closed at the end of the first stage to assess clinical outcome. Studies are stopped early if
the alternative hypothesis is rejected at the .02 level after the first stage of accrual. Otherwise, accrual is
completed and the agent is judged promising if the null hypothesis is rejected. This approach has good
statistical characteristics and is easily adaptable to the typical case in which the actual attained sample
size differs from the planned sample size at the first stage or at the second stage (Green and Dahlberg,
1992).
Single stage designs are also commonly used, particularly when patient accrual is rapid and/or much
time is required to assess the study endpoint. In the latter case, concern over the potential effect on
accrual after a temporary closure must be weighed against concerns about subjecting a larger number of
patients to a potentially toxic regimen. Often the Biostatistician incorporates a formal interim assessment
of adverse events and outcome without discontinuing accrual.
Although response was the traditional endpoint for many Phase II trials of investigational new agents,
there is less expectation of an impact on tumor size for trials involving targeted therapies. Similarly,
Phase II trials of new combinations and regimens typically utilize endpoints other than response. Thus,
primary endpoints for Phase II studies are now more likely to include outcomes such as disease control
rate (stable disease or better, often at a fixed time point), or progression-free or overall survival. With
different endpoints, and with changing patient populations (perhaps restricted to patients more likely to
benefit from a specific targeted therapy), there is more concern about the accuracy of historical data, and
the potential for biases in the results of a single arm Phase II trial. These concerns have lead to
increased use of randomized phase II trials. However, these designs are not without limitations, as
discussed below.
One alternative to randomized designs which may address concerns about biased historical baseline
data is to adjust the Phase II single arm decision criteria to adjust expected individual patient experience
based on prognostic factors. SWOG Biostatisticians collaborated with NCI and other Cooperative
Groups (Korn, et al., 2008) in a study using historic information from Phase II trials in malignant
melanoma. This approach is also now being evaluated for advanced non-small cell lung cancer and for
pancreatic cancer. With support from NCI and data contributed from other Cooperative Groups, SWOG
is constructing historical databases for these two diseases.
Randomized Phase II Trials
Among the arguments presented in favor of randomized Phase II designs are: 1) discomfort with
identification of control values based on historical data; 2) protocol development is quicker and studies
conducted more rapidly when multiple treatment arms can be assessed simultaneously; 3) that these
designs identify ‘signal’ better than a single arm trial. Unfortunately, due to the nature of Phase II testing,
there are always compromises. The small sample sizes considered appropriate for a randomized Phase
II can only be achieved by accepting larger Type 1 and Type 2 errors; for a similar set of null and
alternative hypotheses, a corresponding one-arm Phase II trial requires about half the sample size. A
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simulation study by Taylor, Braun, and Li (2006) indicates that unless there is significant bias in the
choice of the null hypothesis from historic data, one is better off with a single arm trial; moreover, the
notion of conducting multiple arm phase II trials tend to be infeasible; these studies typically involve
agents from more than one pharmaceutical sponsor, each of whom is reluctant to ‘lose’ in such a setting,
even if head to head comparison is not the intended goal of the study. Thus, SWOG is cautious when
considering randomized phase II trials. There are some situations which have called for such a trial,
typically in settings where SWOG has no historical experience from which to draw estimates of a null
value, or when a selection of a regimen for further testing rather than a comparative trial is the aim.
If the goal of the study is to select the most promising regimen (among two or more) for further study, a
randomized Phase II study (selection design) may be reasonable (Simon, Wittes and Ellenburg, 1985
and Liu, Dahlberg and Crowley, 1993). Sample sizes are selected such that choosing the regimen with
the best observed outcome is in fact the correct choice with high probability, when one regimen is better
than the others by a specified amount.
A possible alternative to a randomized Phase II trial with a control group is a Phase II/III trial where the
randomized Phase II trial continues into a Phase III if appropriate conditions are met. The Statistical
Center has also investigated a related Phase III strategy with an early interim look for futility based on a
shorter term endpoint (Goldman, LeBlanc and Crowley, 2008).
Phase III Trials
All SWOG Phase III trials have a named faculty level Biostatistician who oversees the statistical
development of the protocol including refining the hypotheses as needed, defining data collection
protocols, specifying randomization details, defining the data analysis and data monitoring plan and
determining the target sample size. To provide for a comprehensive and definitive test of a novel
regimen relative to a standard treatment, Phase III SWOG trials are typically designed to have close to
90% power to detect moderate improvements in a survival-based endpoint based on a one-sided 0.025level test. Occasionally multiple arms will be tested in the same trial, either in parallel or as a factorial
design. Such trials are rare because of the practical challenges in mounting such efforts. Non-inferiority
trials may also be conducted in SWOG, using principles outlined in Kopecky and Green (2006). Power
calculations are generally made using commercial software or tools available on the Statistical Center
website.
For survival, these calculations are based on Bernstein and Lagakos (1978). Balance on stratification
factors is accomplished using a dynamic allocation scheme (Pocock and Simon, 1985). The patient is
assigned with high probability (e.g., ¾) to the arm that would achieve smaller overall imbalance.
Stopping rules are based on Group sequential designs which preserve the overall error rates but allow
for early stopping if extreme results are observed. In addition to the specification of Type I and Type II
errors, a typical design for a Phase III study would call for specification of the number of interim analyses
(generally 2 or 3) and of a small probability of terminating at each interim analysis if the null hypothesis is
true. SWOG Biostatisticians also typically define a one-sided test of ‘futility’ using a similar early
stopping rule based on testing the alternative hypothesis, rather than performing a test based on
conditional power. The critical p-values chosen for interim stopping are typically the same for the several
analyses and considerably lower than the overall alpha level (typically .1 x alpha, Haybittle, 1971). The
result is a procedure with virtually the same power and level as the fixed sample size procedure, but one
that allows for early termination and permits a final analysis at close to traditional levels (Crowley, Green,
Liu and Wolf, 1994; Fleming, Green, and Harrington, 1984).
Most Phase III trials involve two treatment arms. Multi-arm trials offer special challenges, and the
statistical design must carefully identify the comparisons of interest, with appropriate testing strategies
(including accommodations for multiple testing), and corresponding adjustments to sample size
calculations. Factorial designs require consideration of potential treatment interactions; research by
SWOG statisticians (Green, et al., 2002) show the problems inherent in assuming a two-for-one
assumption when making sample size estimates.
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Phase III Designs of Targeted Therapy
For some newer agents, efficacy is expected to be dependent on expression of the appropriate tumor
target. In some instances (Her2-neu, c-kit) study designs should limit patient eligibility. In other studies,
assessment of the relationship between a marker and patient response to therapy is an inherent part of
the study goals.
There are a number of possible approaches to study designs for targeted therapy, and the efficiencies of
a targeted trial design (restricted to patients positive for the factor) versus randomizing all patients with
respect to the number of patients required for screening and the number of patients needed for
randomization should be evaluated as part of the design process (see e.g., Simon and Maitournam
2004; Hoering, et al. 2008).
To assess some of the factors related to the choice of design, Statistical Center faculty members
investigated the performance of several Phase III clinical trial designs, both for testing the overall efficacy
of a targeted agent and for testing its efficacy in a targeted subgroup of patients with a tumor marker
present (Hoering, et al., 2008). They studied the impact of different designs and different underlying
scenarios assuming continuous markers, and assessed the trade-off between the number of patients on
study and the effectiveness of treatment in the subgroup of marker-positive patients. In general, a
targeted design which randomizes patients with the appropriate marker status performs the best in all
scenarios with an underlying true predictive marker. Randomizing all patients regardless of their marker
values performs as well as or better in most cases than a clinical trial that randomizes the patient to a
treatment strategy based on marker value versus standard of care.
If there is the possibility that the new treatment helps marker negative patients, or that the cut-point
determining marker status has not been well established and the marker prevalence is large enough,
they concluded that the best choice is to randomize all patients regardless of marker values, but using a
design such that both the overall and the targeted subgroup hypothesis can be tested.
An alternative study design is to test whether the strategy of assigning treatment based on individual
markers (targeted assignment) is preferable to standard treatment assignment. In this setting, patients
are either randomized to standard therapy, or randomized to receive treatment based on the level of a
specific marker. However this design is inefficient if a large proportion of patients in the “targeted
assignment” arm are assigned to the standard treatment (Hoering, et al., 2008).
Correlative Analyses
In addition to the primary analysis of the therapeutic study, biologic or translational correlative analyses
may be included as part the clinical protocol. The main goal and endpoint should be stated in the
protocol (e.g., to explore the prognostic value of EGRF status with respect to survival of advanced nonsmall lung cancer patients receiving Erlotinib in combination with standard chemotherapy).
Assumptions concerning endpoints, length of accrual and follow-up and survival probabilities should
match those on the treatment protocol (if the study is associated with just one clinical protocol). In
addition, designs should acknowledge the expected number of submitted specimens from the study.
The analysis plan should include the specific test statistics or statistical models (e.g., Cox proportional
hazards model) to be used and the magnitude of difference there will be power to detect (since the
sample size generally will be fixed) by the clinical study design. As a result of this and sample
submission rates in some cases the proposed analyses will not have optimal power but anticipated
power should be specified.
Data and Safety Monitoring
There is no formal Data and Safety Monitoring Committee (DSMC) for the majority of SWOG phase II
trials, with the exception of randomized phase II trials that have an explicit comparison between arms as
a primary objective. Toxicity and accrual monitoring are done routinely by the Study Coordinator, study
Biostatistician, and the disease committee chair. Response monitoring is done by the study
Biostatistician and Study Coordinator. Accrual reports are generated weekly, and toxicity reports are
generated monthly. In addition, a Biostatistician at the Statistical Center, the Serious Adverse Event
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Program Manager at the Operations Office, and the Executive Officer monitor toxicities on an ongoing
basis. The SWOG Executive Committee evaluates moribund phase I and II studies several times a year,
and studies which will never realistically achieve their objectives are closed.
All Phase III studies managed by SWOG are reviewed by a single DSMC that conforms to the NCI
Cooperative Group Data Monitoring Committee policy. This committee consists of the following: three
members of the Group (a patient advocate and two clinicians), a statistician not involved with the Group,
three non-voting representatives from the NCI, and the Group Statistician or his designee (also nonvoting). Detailed interim results are generated at the Statistical Center and are presented only to this
DSMC and not to the Group as a whole. The committee recommends when to close the study and when
to report the results, using the stopping boundaries in the protocol as a guideline. Protocols are
designed with stopping boundaries based on group sequential designs that preserve the overall error
rates but allow for early stopping if extreme results are observed. Phase III accrual monitoring follows
th
th
th
the CTEP accrual rule where accrual rates are evaluated at the 5 , 6 and 8 quarters of the trial.
Studies may be closed or redesigned based on the accrual rule. Accrual is also presented to the DSMC
at each meeting. The DSMC also reviews requests for access to unreleased data for the purpose of
planning new trials. Considerations include whether there are patients still receiving protocol treatment,
the time until anticipated final analysis, and whether information is requested by treatment arm.
Between 2006 and 2010, the median number of study summaries presented to the DSMC has been 22
studies per meeting (range 17-23), with 6 studies (range 5-9) scheduled for formal discussions. During
this 5 year period, the DSMC has recommended early termination of three studies based on negative
results at an interim analysis (1), external evidence (1), and safety concerns (1). Two studies were
closed due to poor accrual based on committee recommendation. The committee approved 7 requests
for early release of data to select individuals for purposes of planning the next generation trial or analysis
of secondary objectives unrelated to the primary treatment comparison.
Data Reporting and Analyses
Data Reporting
All open and most recently closed studies are described in the twice yearly Report of Studies, which
forms the basis for much of the discussion in the Disease Committees at the twice-yearly Group
meetings.
Data are as current as possible, subject to the need for data review by the Study Coordinators. The
description of each study includes a summary face sheet, schema (as applicable), accrual information by
arm and by institution, stratification factors, patient characteristics and toxicity information. Response
and survival comparisons for Phase III studies are presented only when the study has been approved for
release by the Data and Safety Monitoring Committee.
Standard report modules extract data from the database and create tables. The Statistician’s Report
Worksheet (SRW) application creates the report contents. The Report of Studies (ROS) includes
chapters for each disease committee, as well as the Cancer Control and Prevention program. An
additional section contains information on accrual to all Group studies by institution, study type and by
committee.
Analysis of Studies
Most analyses for monitoring and for publication for Phase II and Phase III studies use tables and
survival curves generated from SRW. The use of SRW permits standardization of analysis and reporting
across studies and disease committees. This standardization is made possible by enforcing common
data coding conventions across different diseases and study types. The use of SRW provides a
consistent approach to testing and verification of analysis code for commonly required analyses,
compared to having all analyses based on individual SAS programs.
Additional analyses of data extracted from the database are often necessary before a study can be
published. SAS™ procedure LIFETEST is generally used for logrank and stratified logrank tests, and
the SAS™ procedure PHREG is used for proportional hazards regression and testing alternative
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hypotheses. Dichotomous data are analyzed using the procedures FREQ and LOGISTIC. Longitudinal
data are analyzed using PROC MIXED.
For Phase III studies, the primary efficacy analysis should stratify or adjust with Cox regression analysis
based on the variables and coding used in the dynamic randomization program. Stratified analyses are
typically possible because only a small number of factors known to be strongly associated with patient
outcome are included in the randomization scheme.
Locally developed analysis software is used when necessary, especially for Cox regression diagnostics,
for recursive partitioning, and for longitudinal data with non-ignorable missingness. In addition, faculty
Biostatisticians are involved in ongoing methodologic research for more efficient trial designs and
improved analytic techniques. While the methods research is separately funded (R01 CA090998)
(LeBlanc, PI), it is motivated by clinical and translational activities within SWOG.
Prostate Cancer Prevention Trial (PCPT)
Overview
The Prostate Cancer Prevention Trial (PCPT) was a Phase III, randomized, double-blind, placebocontrolled trial of finasteride for the prevention of carcinoma of the prostate. The primary objective of the
PCPT was to test the difference in the histologically proven prevalence of carcinoma of the prostate
between these two groups of randomized participants. Other objectives included assessment of the
effect of finasteride on the stage and grade of carcinoma at the time of diagnosis, and estimation of the
difference between the two groups in (1) total and prostate cancer-specific mortality and (2) the
incidence and severity of benign prostatic hyperplasia (BPH). A total of 18,882 essentially healthy men,
aged 55 and older, were randomized to receive finasteride (5 mg daily) or placebo for seven years. At
the end of seven years, all participants not previously diagnosed with prostate cancer were asked to
undergo a prostate biopsy.
The PCPT was an intergroup study with participation from 213 study sites in the United States and
Canada. The trial was activated on October 13, 1993 and closed to enrollment on December 6, 1996;
the last participant was randomized on May 16, 1997.
Results
The PCPT was closed early on June 24, 2003 based on an independent Data and Safety Monitoring
Committee recommendation. The study results were published in the online version of the New England
Journal of Medicine and appeared in the print journal on July 17, 2003. The analysis of the data
revealed that men in the finasteride group who were evaluated were 24.8% less likely to develop
prostate cancer when compared to the men evaluated who were in the placebo group. Although the
men taking finasteride had fewer prostate cancers, they had an increased number of high-grade prostate
cancers. In the entire group of men assigned to finasteride who were evaluated, 6.4% had high-grade
cancers while 5.1% of the men evaluated in the placebo had high-grade cancers.
Several manuscripts have been published since the closure of the PCPT. Publication topics have
included the effect of finasteride on the pathology of prostate cancer, prostate specific antigen (PSA),
digital rectal exams and the detection of prostate cancer, the assessment of prostate cancer risk,
finasteride and prostatic intraepithelial neoplasia (PIN), the effect of lifestyle characteristics on PSA,
erectile dysfunction and subsequent cardiovascular disease and the design, biases and interpretation of
the PCPT study results, and a comprehensive statistical model accounting for multiple biases and high
grade prostate cancer. Analyses of PCPT data are ongoing and future publications of interest will focus
on important topics such as benign prostatic hyperplasia (BPH) and prostate cancer, the side-effects of
finasteride related to treatment efficacy as well as additional quality of life and urologic issues associated
with this study.
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New Studies
A program project (P01) was initiated in 2005 to make use of a specific set of specimens collected during
the course of the PCPT (serum, white blood cells, prostate biopsy tissue). This program project is a
multi-institutional study and is investigating various areas of research including:
•
•
•
•
•
Androgen metabolism in the PCPT (Reichardt, University of Sydney)
Diet and diet-related factors (Kristal, Fred Hutchinson Cancer Research Center)
Insulin-like growth factor axis and insulin resistance (Pollack, McGill)
Genotypic and phenotypic studies of inflammation (Platz, Johns Hopkins)
Oxidative damage and DNA repair (Santella, Columbia)
The goal of this program project is to study the genetic, metabolic and environmental factors associated
with the risks of prostate cancer and high grade prostate cancer, to investigate the effects of these
factors on the efficacy of the study agent, finasteride, and to understand the mechanisms underlying the
risk-factor associations. In addition to individual project aims, there are cross-project aims to investigate
the joint effects of the biologic markers. Finally, traditional and newer innovative statistical methods will
be used to develop prognostic groups based on the combined results from each of the projects.
The Selenium and Vitamin E Cancer Prevention Trial (SELECT)
SELECT is a Phase III, double-blind, placebo-controlled study designed to assess the effect of selenium
and vitamin E, alone and in combination, on prostate cancer incidence as determined by routine clinical
management. Between August 22, 2001, and closure of accrual on June 24, 2004, SELECT
randomized 35,533 participants age 55 and over (50 and over for African Americans), achieving minority
representation of 21% (15% African Americans). A total of 427 Study Sites throughout the United
States, Puerto Rico and Canada randomized participants to the trial.
On September 15, 2008, the independent SELECT Data and Safety Monitoring Committee
recommended the discontinuation of study supplements due to convincing evidence that the
supplements did not prevent prostate cancer. The SELECT scientific leadership concurred with the
DSMC’s recommendations and decided to stop the intervention. Study Sites were notified of the results
on October 23, 2008, and participants were notified shortly thereafter. The DSMC continues to review
the status of SELECT and its ancillary studies.
Until November 1, 2009, Study Sites followed men as they had during the active supplementation phase
(twice yearly for men without prostate cancer, annually for men with prostate cancer). Beginning as
early as November 1, 2009, Study Sites began conducting Transition Visits, final exit visits consisting of
follow-up for endpoints and prostate health, a blood sample for participants diagnosed with prostate
cancer, unblinding of the participant to the intervention assignment and consent for Centralized Followup (CFU). Participants who agree to further follow-up are transitioned to an annual contact conducted
by the SELECT Statistical Center. Study Sites have completed all Transition Visits and subsequent data
cleanup and regulatory notifications, and have ended their participation in SELECT. A total of 17,635
participants have been registered to CFU.
Data Operations staff continue to review follow-up data, which are now submitted exclusively by
participants. Although Study Sites are finished with their responsibilities, participants continue to contact
the Statistical Center expressing interest in transitioning to CFU. For these participants, Statistical
Center staff obtain informed consent and process signed consent forms. For participants already
consented to CFU, Statistical Center staff obtain release of information forms and new data collection
forms from participants who report study endpoints. The forms are scanned or faxed, reviewed and data
entered using Teleform verification software. In addition, ancillary study participation is offered to
participants as appropriate.
Retention of participants continues to be a vital component of SELECT. Retention staff will continue to
support the retention of participants throughout the CFU phase, preparing newsletters and content for
the SELECT public website. Specially trained staff responds to participant questions and concerns.
This communication occurs by telephone, e-mail or postal service. Additionally, when a participant or
family member reports a study endpoint or a significant life event (e.g., the death of a spouse), the
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Statistical Center contacts the participant or family member and provides support and resources in
addition to collecting additional data as necessary.
Centralized Follow-up (CFU) begins with a welcome letter, mailed to the participant within approximately
one month of his registration to CFU. Thereafter, during the month of the participant’s birth, the vendor
under contract with the Statistical Center prints a questionnaire in booklet form and mails it to the
participant. There are four versions: one for participants not currently diagnosed with prostate cancer
and another for those diagnosed with prostate cancer, each available in Spanish and English. The
participant may either mail his completed booklet to the Statistical Center using the prepaid return
envelope, or he may choose to enter his data via a secure website, MySELECTData, which was
released in 2011. The MySELECTData application allows participants to submit their annual health
questionnaire on-line during a specified time interval. Participants may review and make updates to their
personal contact information at any time.
Participants who report study endpoints are asked to provide a release of information, which the
Statistical Center uses to obtain relevant medical records and tissue as appropriate. In addition to
serving as the gateway to the secure data entry system, the public website will continue to be a key
source of information for participants about study activities. The public website will be updated
frequently throughout CFU. The Statistical Center expects to receive frequent communication from
participants throughout CFU, by telephone, e-mail and mail, and in both the English and Spanish
languages. Specially trained retention staff will handle this communication and will arrange for
translation of materials into Puerto Rican Spanish.
A process has been developed for inviting and reviewing proposals for use of the extensive SELECT
biorepository. In the spring of 2011 the first group of proposals was approved.
Statistical Applications and Research
Statistical Center faculty participate in scholarly activities that are not directly related to a specific
protocol or which reflect research efforts not directly evaluating interventions. In particular, several
faculty statisticians pursue statistical methods research for a fraction of their time on an R01, Statistical
Methods for Clinical Studies (PI, Dr. Michael LeBlanc). The emphases currently are design and analysis
strategies for Phase III trials and survival analysis (particularly graphical and other exploratory methods).
Other efforts are devoted toward improving other aspects of multicenter clinical trials. Publications
highlighting the breadth of Statistical Cancer research activities are listed below.
2010
1. Randall LM, Monk BJ, Moon J, Parker R, Al-Ghazi M, Wilczynski S, Fruehauf JP, Markman M,
Burger RA. Prospective evaluation of an in vitro radiation resistance assay in locally advanced
cancer of the uterine cervix: a Southwest Oncology Group study. Gynecol Oncol 119(3):417421, 2010. PMID: 20846714
2. Herbst RS, Kelly K, Chansky K, Mack PC, Franklin WA, Hirsch FR, Atkins JN, Dakhil SR, Albain
KS, Kim ES, Redman M, Crowley JJ, Gandara DR. Phase II selection design trial of concurrent
chemotherapy and cetuximab versus chemotherapy followed by cetuximab in advanced-stage
non-small-cell lung cancer: Southwest Oncology Group study S0342. J Clin Oncol 28(31):47474754, 2010. PMID: 20921467
3. Gitlitz B, Moon J, Glisson BS, Reimers HJ, Bury MJ, Floyd JD, Schulz TK, Sundaram PK, Ho C,
Gandara DR. Sorafenib in platinum-treated patients with extensive stage small cell lung cancer;
a Southwest Oncology Group (SWOG 0435) Phase II trial. J Thorac Oncol 5(11):1835-1840,
2010. PMID: 20881645
4. Lara PN, Jr, Chansky K, Shibata T, Fukuda H, Tamura T, Crowley J, Redman MW, Natale R,
Saijo N, Gandara DR. Common arm comparative outcomes analysis of Phase 3 trials of cisplatin
+ irinotecan versus cisplatin + etoposide in extensive stage small cell lung cancer; final patientlevel results from Japan Clinical Oncology Group 9511 and Southwest Oncology Group 0124.
Cancer 116(24):5710-5715, 2010. PMID: 20737417, PMCID: PMC2994945
5. Blanke CD, Chansky K, Christman KL, Hundahl SA, Issell BF, Van Veldenhuizen PJ, Jr, Budd
GT, Abbruzzese JL, Macdonald JS. A Southwest Oncology Group Phase II study of trimetrexate,
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6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
August
5-fluorouracil, and leucovorin in unresectable or metastatic adenocarcinoma of the stomach. Am
J Clin Oncol 33(7):117-120, 2010. PMID: 19770625; PMCID: PMC2967385
Zonder JA, Crowley J, Hussein MA, Bolejack V, Moore DF, Sr, Whittenberger BF, Abidi MH,
Durie BGM, Barlogie B. Lenalidomide and high-dose dexamethasone compared with
dexamethasone as initial therapy for multiple myeloma: a randomized Southwest Oncology
Group trial (S0232). Blood 116(26):5838-5841, 2010. PMID: 20876454
Medeiros BC, Othus M, Fang M, Roulston D, Appelbaum FR. Prognostic impact of monosomal
karyotype in young adult and elderly acute myeloid leukemia: the Southwest Oncology Group
(SWOG) experience. Blood 116(13):2224-2228, 2010. PMID: 20562328
Othus M, Li Y. A Gaussian Copula model for multivariate survival data. Stat Biosci 2:154-179,
2010.
Allen JD, Othus MK, Shelton RC, Li Y, Norman N, Tom L, del Carmen MG. Parental decision
making about the HPV vaccine. Cancer Epidemiol Biomarkers Prev 19(9):2187-2198, 2010.
PMID: 20826829
Allen J, Othus M, Hart A Jr, Tom L, Li Y, Berry D, Bowen D. A randomized trial of a computertailored decision aid to improve prostate cancer screening decisions: from the Take the Wheel
trial. Cancer Epidemiol Biomarkers Prev 19(9):2172-2186, 2010. PMID: 20716619
Albain KS, Barlow WE, Shak S, Hortobagyi GN, Livingston RB, Yeh I-T, Ravdin P, Bugarini R,
Baehner FL, Davidson NE, Sledge GW, Winer EP, Hudis C, Ingle JN, Perez EA, Pritchard KI,
Shepherd L, Gralow JR, Yoshizawa C, Allred DC, Osborne CK, for the Breast Cancer Intergroup
of North America. Prognostic and predictive value of the 21-gene recurrence score assay in
postmenopausal women with node-positive, oestrogen-receptor-positive breast cancer on
chemotherapy: a retrospective analysis of a randomised trial. The Lancet 11(1):55-65, 2010.
PMID: 20005174
de Gramont A, Hubbard J, Shi Q, O'Connell MJ, Buyse M, Benedetti J, Bot B, O'Callaghan C,
Yothers G, Goldberg RM, Blanke CD, Benson A, Deng Q, Alberts SR, André T, Wolmark N,
Grothey A, Sargent D. Association between disease-free survival and overall survival when
survival is prolonged after recurrence in patients receiving cytotoxic adjuvant therapy for colon
cancer: simulations based on the 20,800 patient ACCENT data set. J Clin Oncol 28(3):460-465,
2010. PMID: 20008641; PMCID: PMC2815708
Seymour L, Ivy PS, Sargent D, Spriggs D, Baker L, Rubenstein L, Ratain MJ, LeBlanc M,
Stewart D, Crowley J, Groshen S, Humphrey JS, West P, Berry D. The design of Phase II
clinical trials testing cancer therapeutics: consensus recommendations from the Clinical Design
Task Force of the National Cancer Institute Investigational Drug Steering Committee. Clin
Cancer Res 16(6):1764-1769, 2010. PMCID: PMC2840069
Walter RB, Kantarjian HM, Huang X, Pierce SA, Sun Z, Gundacker HM, Ravandi F, Faderl SH,
Tallman MS, Appelbaum FR, Estey EH. Effect of complete remission and responses less than
complete remission on survival in acute myeloid leukemia: a combined Eastern Cooperative
Oncology Group, Southwest Oncology Group, and M. D. Anderson cancer Center study. J Clin
Oncol 28(10):1766-1771, 2010. PMID: 20159819; PMCID: PMC2849766
Stasik CJ, Nitta H, Zhang W, Mosher CH, Cook JR, Tubbs RR, Unger JM, Brooks TA, Persky
DO, Wilkinson ST, Grogan TM, Rimsza LM. Increased MYC gene copy number correlates with
increased mRNA levels in diffuse large B-cell lymphoma. Haematologica 95(4):597-603, 2010.
PMID: 20378577; PMCID: PMC2857189
Slovak ML, Bedell V, Lew D, Albain KS, Ellis GK, Livingston RB, Martino S, Perez EA,
Hortobagyi GN, Sher D, Stock W. Screening for clonal hematopoiesis as a predictive marker for
development of therapy-related myeloid neoplasia (t-MN) following neoadjuvant therapy for
breast cancer: a Southwest Oncology Group study (S0012). Breast Cancer Res Treat
119(2):391-398, 2010. PMID: 19851858; PMCID: PMC2843456
Ho PA, Alonzo TA, Kopecky KJ, Miller KL, Kuhn J, Zeng R, Gerbing RB, Raimondi SC, Hirsch
BA, Oehler V, Hurwitz CA, Franklin JL, Gamis AS, Petersdorf SH, Anderson JE, Reaman GH,
Baker LH, Willman CL, Bernstein ID, Radich JP, Appelbaum FR, Stirewalt DL, Meshinchi S.
Molecular alterations of the IDH1 gene in AML: a Children's Oncology Group and Southwest
Oncology Group study. Leukemia 24(5):909-913, 2010. PMID: 20376086
Markman M, Moon J, Wilczynski S, Lopez AM, Rowland KMJ, Michelin DP, Lanzotti VJ,
Anderson GL, Alberts DS. Single agent carboplatin versus carboplatin plus pegylated liposomal
doxorubicin in recurrent ovarian cancer: final survival results of a SWOG (S0200) phase 3
randomized trial. Gynecol Oncol 116(3):323-325, 2010. PMID: 20044128
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19. Cook ED, Arnold KB, Hermos JA, McCaskill-Stevens W, Moody-Thomas S, Probstfield JL,
Hamilton SJ, Campbell RD, Anderson KB, Minasian LM. Impact of supplemental site grants to
increase African American accrual for the Selenium and Vitamin E Cancer Prevention Trial. Clin
Trials 7(1):90-99, 2010. PMID: 20156960
20. Dorff TB, Goldman B, Pinski JK, Mack PC, Lara PN, Jr, Van Veldenhuizen PJ, Jr, Quinn DI,
Vogelzang NJ, Thompson IM, Jr, Hussain MHA. Clinical and correlative results of SWOG
S0354: a Phase II trial of CNT0328 (siltuximab) a monoclonal antibody against interleukin-6, in
chemotherapy-pretreated patients with castration-resistant prostate cancer. Clin Cancer Res
16(11):3028-2034, 2010. PMID: 20484019; PMCID: PMC2898710
21. Harigopal M, Barlow WE, Tedeschi G, Porter PL, Yeh I-T, Haskell C, Livingston R, Hortobagyi
GN, Sledge G, Shapiro C, Ingle JN, Rimm DL, Hayes DF. Multiplexed assessment of the
Southwest Oncology Group-directed intergroup breast cancer trial S9313 by AQUA shows that
both high and low levels of HER2 are associated with poor outcome. Am J Pathol 176(4):16391647, 2010. PMID: 20150438; PMCID: PMC2843456
22. Clark JI, Moon J, Hutchins LF, Sosman JA, Kast WM, DaSilva DM, Liu PY, Thompson JA,
Flaherty LE, Sondak VK. Phase 2 trial of combination thalidomide plus temozolomide in patients
with metastatic malignant melanoma: Southwest Oncology Group S0508. Cancer 116(2):424431, 2010. PMID: 19918923; PMCID: PMC2811758
23. van Glabbeke M, Verweij J, Blay J-Y, Debiec-Rychter M, Demetri GD, Heinrich MC, Borden EC,
Redman BG, Blanke CD, Rankin C, Crowley J, Casali P, von Mehren M, Fletcher C, Fletcher J,
Owzar K, Zalcberg J, Simes J, Bramwell-Wesley V, The Gm-ag. Comparison of two doses of
imatinib for the treatment of unresectable or metastatic gastrointestinal stromal tumors: a metaanalysis of 1,640 patients. J Clin Oncol 28(7):1247-1253, 2010. PMID: 20124181. PMCID:
PMC2834472
24. Williamson SK, Moon J, Huang CH, Guaglianone PP, LeBlanc M, Wolf GT, Urba SG. Phase II
evaluation of sorafenib in advanced and metastatic squamous cell carcinoma of the head and
neck: Southwest Oncology Group study S0420. J Clin Oncol 28(20):3330-3335, 2010. PMID:
20498388; PMCID: PMC2903329
25. Sweetenham JW, Goldman B, LeBlanc ML, Cook JR, Tubbs RR, Press OW, Maloney DG,
Fisher RI, Rimsza LM, Braziel RM, Hsi ED. Prognostic value of regulatory T cells, lymphomaassociated macrophages, and MUM-1 expression in follicular lymphoma treated before and after
the introduction of monoclonal antibody therapy: a Southwest Oncology Group study. Ann
Oncol 21(6):1196-1202, 2010. PMID: 19875761; PMCID: PMC2875547
26. Petrylak DP, Tangen CM, Van Veldhuizen PJ, Jr, Goodwin JW, Twardowski PW, Atkins JN,
Kakhil SR, Lange MK, Mansukhani M, Crawford ED. Results of the Southwest Oncology Group
phase II evaluation (study S0031) of ZD1839 for advanced transitional cell carcinoma of the
urothelium. BJU Int 105(3):317-21, 2010. PMID: 19888985
27. Moinpour CM, Vaught NL, Goldman B, Redman MW, Philip PA, Millwood B, Lippman SM, Seay
TE, Flynn PJ, O'Reilly EM, Rowland KM, Wong RP, Benedetti J, Blanke CD. Pain and emotional
well-being outcomes in Southwest Oncology Group-directed intergroup trial S0205: a phase III
study of gemcitabine plus cetuximab versus gemcitabine as first-line therapy in patients with
advanced pancreas cancer. J Clin Oncol 28(22):3611-3616, 2010. PMID: 20606094
28. Barlogie B, Attal M, Crowley J, van Rhee F, Szymonifka J, Moreau P, Durie BGM, Harousseau
J-L. Long-term follow-up of autotransplantation trials for multiple myeloma: update of protocols
conducted by the Intergroupe Francophone du Myelome, Southwest Oncology Group, and the
University of Arkansas for Medical Sciences. J Clin Oncol 28(7):1209-1214, 2010. PMID:
20085933: PMCID: PMC2834471
29. Tiersten AD, Moon J, Smith HO, Wilczynski SP, Robinson WR, 3rd, Markman M, Alberts DS.
Chemotherapy resistance as a predictor of progression-free survival in ovarian cancer patients
treated with neoadjuvant chemotherapy and surgical cytoreduction followed by intraperitoneal
chemotherapy: a Southwest Oncology Group study. Oncology 77(6):395-399, 2010. PMID:
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30. Pisters KMW, Vallières E, Crowley JJ, Franklin WA, Bunn PA, Jr, Ginsberg RJ, Putnam JB, Jr,
Chansky K, Gandara D. Surgery with or without preoperative paclitaxel and carboplatin in earlystage non-small-cell lung cancer: Southwest Oncology Group trial S9900, an Intergroup,
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31. LeBlanc M, Kooperberg C. Boosting predictions of treatment success. Proc Natl Acad Sci U S A
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32. Samlowski WE, Moon J, Tuthill RJ, Heinrich MC, Balzer-Haas NS, Merl SA, DeConti RC,
Thompson JA, Witter MT, Flaherty LE, Sondak VK. A Phase II trial of imatinib mesylate in
merkel cell carcinoma (neuroendocrine carcinoma of the skin). Am J Clin Oncol 33(5):495-499,
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33. Kuptsova-Clarkson N, Ambrosone CB, Weiss J, Baer MR, Sucheston LE, Zirpoli G, Kopecky KJ,
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35. Medeiros BC, Othus M, Fang M, Roulston D, Appelbaum FR. Prognostic impact of monosomal
karyotype in young adult and elderly acute myeloid leukemia: the Southwest Oncology Group
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36. Yao S, Barlow WE, Albain KS, Choi J-Y, Zhao H, Livingston RB, Davis W, Rae JM, Yeh I-T,
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37. Philip PA, Benedetti J, Corless CL, Wong R, O'Reilly EM, Flynn PJ, Rowland KM, Atkins JN,
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Blanke CD. Phase III study comparing gemcitabine plus cetuximab versus gemcitabine in
patients with advanced pancreatic adenocarcinoma: Southwest Oncology Group-directed
Intergroup trial S0205. J Clin Oncol 28(22):3605-3610, 2010. PMID: 20606093, PMCID:
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38. Gold PJ, Goldman B, Iqbal S, Leichman LP, Zhang W, Lenz H-J, Blanke CD. Cetuximab as
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39. Albain KS, Barlow WE. In the interest of full disclosure – Author’s reply. In: Lancet Oncology
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40. Hartmann E, Campo E, Wright G, Lenz G, Salaverria I, Jares P, Xiao W, Braziel R, Rimsza L,
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41. Yao S, Barlow W, Albain K, Choi JY, Zhao H, Livingston R, Davis W, Rae J, Yeh IT, Hutchins L,
Ravdin P, Martino S, Lyss A, Osborne CK, Abeloff M, Hortobagyi G, Hayes DF, Ambrosone C.
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disease-free survival in SWOG 8897 clinical trial for breast cancer. In: Clinical Cancer
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42. Tallman M, Kim HT, Montesinos P, Appelbaum F, de la Serna J, Bennett JM, Deben G,
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Willman CL, Sanz MA. Does microgranular variant morphology of acute promyelo-cytic leukemia
independently predict for a less favorable outcome compared with classical M3 APL? A joint
study of North American Intergroup and PETHEMA Group. In: Blood 116(25):5650-5659, 2010.
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43. Schenk JM, Kristal AR, Neuhouser ML, Tangen CM, White E, Lin DW, Kratz M, Thompson IM.
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44. Baker SG, Darke AK, Pinsky P, Parnes HL, Kramer BS. Transparency and reproducibility in data
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45. Neuhouser ML, Till C, Kristal A, Goodman P, Hoque A, Platz EA, Hsing AW, Albanes D, Parnes
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46. Kristal AR, Price DK, Till C, Schenk JM, Neuhouser ML, Ockers S, Lin DW, Thompson IM, Figg
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47. Price DK, Chau CH, Till C, Goodman PJ, Baum CE, Ockers SB, English BC, Minasian L, Parnes
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48. Kristal A, Arnold K, Neuhouser ML, Goodman P, Albanes D, Thompson IM. Diet, supplement
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differences (SNDs) in the dbSNP database may lead to errors in genotyping and haplotyping
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DeMarzo AM, Platz EA. Human papillomavirus types 16, 18 and 31 serostatus and prostate
cancer risk in the Prostate Cancer Prevention Trial. In: Cancer Epidemiology Biomarkers and
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53. Platz E, Sutcliffe S, DeMarzo AM, Drake CG, Rifai N, Hsing A, Hoque A, Neuhouser M,
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54. Hoque A, Ambrosone C, Goodman P, Tangen C, Kristal A, Lucia MS, Wang Q, Kappil M,
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55. Wang M, Caircross G, Shaw E, Jenkins R, Scheithauer B, Brachman D, Buckner J, Fink K,
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56. Pisters KMW, Vallieres E, Crowley J, Franklin W, Bunn PA, Ginsberg RJ, Putnam JB, Chansky
K, Gandara D. Surgery with and without induction paclitaxel and carboplatin chemotherapy in
early stage non-small cell lung cancer: Southwest Oncology Group trial S9900, an intergroup,
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57. Dunn BK, Richmond ES, Minasian LM, Ryan AM, Ford LG. A nutrient approach to prostate
cancer prevention: the Selenium and Vitamin E Cancer Prevention trial (SELECT). In: Nutrition
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58. Thompson IM. Editorial Comment. Urology 75(3):509-510, 2010. PMID: 20211359;
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59. Rutkowski P, van Glabbeke M, Rankin C, Ruka W, Rubin BP, Rubin BP, Debiec-Rychter M,
Lazar A, Gelderblom H, Sciot S, Lopez-Terrada D, Hohenberger P, van Oosterom AT, Schuetze
S. Imatinib mesylate in advanced dermatofibrosarcoma protuberans (DFSP) – pooled analysis of
two phase II clinical trials. In: Journal of Clinical Oncology, 28:1772-1779, 2010.
PMID: 20194851; PMC3040044
60. Advani A, Gundacker H, Sala-Torra O, Radich J, Lai R, Slovak ML, Lancet JE, Coutre S, Stuart
RK, Mims M, Stiff P, Appelbaum F. Southwest Oncology Group study S0530: a phase 2 trial of
clofarabine and cytarabine for relapsed or refractory acute lymphocytic leukemia. In: British
Journal of Haematology 151(5):430-434, 2010. PMID: 21113977; PMC3058291
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61. Scoggins JF, Ramsey SD. A national cancer clinical trials system for the 21st Century:
reinvigorating the NCI Cooperative Group. Journal of the National Cancer Institute 102(17):1371,
2010. PMID: 20682918; PMC2935476.
62. Ludwig H, Bolejack V, Crowley J, Blade J, San Miguel J, Kyle RA, Rajkumar SV, Shimizu K,
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Attal M, Barlogie B, Stewart AK, Durie B. Survival and years of life lost in different age cohorts of
of patients with multiple myeloma. In: Journal of Clinical Oncology, 28(9):1599-1605, 2010.
PMID: 20177027
63. Unger JM, Albain KS. Reply to correspondence re: Racial disparities in cancer survival among
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Wickerham DL, Djulbegovic B, Slingluff CL. Preliminary evaluation of factors associated with
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65. Sparano JA, Pisano ED, White JR, Hunt KK, Mamounas EP, Perez EA, Hortobagyi GN, Gralow
JR, Comis RL. Recommendations for research priorities in breast cancer by the coalition of
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66. Albain KS, Carey L, Gradishar WJ, Gralow JR, Lipton A, Rugo H, Tripathy D, Peck S, Abair T,
Pegram M. Proceedings of the First Global Workshop on Breast Cancer: pathways to the
evaluation and clinical develop-ment of novel agents for breast cancer. In: Clinical Breast
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67. Swain S, Jeong JH, Geyer CE, Costantino JP, Pajon ER, Fehrenbacher LF, Atkins J, Polikoff J,
Vogel VG, Erban JK, Rastogi P, Livingston RB, Perez EA, Mamounas EP, Land SR, Ganz PA,
Wolmark N. Longer therapy and iatrogenic amenorrhea improve breast cancer survival. In: New
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69. Partridge A, Archer L, Kornblith A, Gralow J, Grenier D, Perez E, Wolff A, Wang X, Kastrissios,
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Melnick A, Reed JC, Horning SJ, Gascoyne RD. Expression of p21 protein predicts clinical
outcome in CLBCL patients treated with R-CHOP but not CHOP: a prospective ECOG and
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2009
1. Markman M, Liu P-Y, Moon J, Monk BJ, Copeland L, Wilcyznski S, Alberts D. Impact on survival
of 12 versus 3 monthly cycles of paclitaxel (175 mg/m²) administered to patients with advanced
ovarian cancer who attained a complete response to primary platinum-paclitaxel: follow-up of a
Southwest Oncology Group and Gynecologic Oncology Group phase 3 trial. Gynecol Oncol
114(2):195-198, 2009. PMID: 19447479; PMCID: PMC2744303
2. Adelstein DJ, Moon J, Hanna E, Shankar Giri PG, Mills GM, Wolff GT, Urba SG. Docetaxel,
cisplatin, and fluorouracil induction chemotherapy followed by accelerated
fractionation/concomitant boost radiation and concurrent cisplatin in patients with advanced
squamous cell head and neck cancer: a Southwest Oncology Group Phase II trial (S0216).
Head Neck 32(2):221-228, 2009. PMID: 19557750
3. Philip PA, Mooney M, Jaffe D, Eckhardt G, Moore M, Meropol N, Emens L, O'Reilly E, Korc M,
Ellis L, Benedetti J, Rothenberg M, Hingorani S, Berlin J, Tepper J. Consensus report of the
National Cancer Institute clinical trials planning meeting on pancreas cancer treatment. J Clin
Oncol 27(33):5660-5669, 2009. PMID: 19858397
4. Albain KS, Barlow WE, Ravdin PM, Farrar WB, Burton GV, Ketchel SJ, Cobau CD, Levine EG,
Ingle JN, Pritchard KI, Lichter AS, Schneider DJ, Abeloff MD, Henderson IC, Muss HB, Green
SJ, Lew D, Livingston RB, Martino S, Osborne CK, for the Breast Cancer Intergroup of North
America. Adjuvant chemotherapy and timing of tamoxifen in postmenopausal patients with
endocrine-responsive, node-positive breast cancer: a phase 3, open-label, randomised
controlled trial. The Lancet 374(9707):2055-2063, 2009. PMID: 20004966
5. Kooperberg C, LeBlanc M, Dai JY, Rajapakse I. Structures and assumptions: strategies to
harness gene x gene and gene x environment interactions in GWAS. Stat Sci 24(4):472-488,
2009. PMID: 20640184; PMCID: PMC2904990
6. Chauncey TR, Gundacker H, Shadman M, List AF, Dakhil SR, Erba HP, Slovak ML, Chen I-M,
Willman CL, Kopecky KJ, Appelbaum FR. Sequential phase II Southwest Oncology Group
studies (S0112 and S0301) of daunorubicin and cytarabine by continuous infusion, without and
with ciclosporin, in older patients with previously untreated acute myeloid leukaemia. Br J
Haematol 48(1):48-58, 2009. PMID: 19821823; NIHMS152440
7. Kooperberg C, LeBlanc M, Dai JY, Rajapakse I. Structures and assumptions: strategies to
harness gene x gene and gene x environment interactions in GWAS. Stat Sci 24(4):472-488,
2009.
8. Lippman SM, Klein EA, Goodman PJ, Lucia MS, Thompson IM, Ford LG, Parnes HL, Minasian
LM, Gaziano JM, Hartline J, Parsons JK, Bearden JD, III, Crawford ED, Goodman GE, Claudio
J, Winquist E, Cook ED, Karp DD, Walther P, Lieber MM, Kristal AR, Darke AK, Arnold KB, et al.
Effect of selenium and vitamin E on risk of prostate cancer and other cancers: the Selenium and
Vitamin E Cancer Prevention Trial (SELECT). JAMA 301(1):39-51, 2009. PMID: 19066370
9. Becker PS, Kopecky KJ, Wilks AN, Chien S, Harlan JM, Willman CL, Petersdorf SH, Stirewalt
DL, Papayannopoulou T, Appelbaum FR. Very late antigen-4 function of myeloblasts correlates
with improved overall survival for patients with acute myeloid leukemia. Blood 113(4):866-874,
2009. PMID: 18927435
10. Schwartz JL, Kopecky KJ, Mathes RW, Leisenring WM, Friedman DL, Deeg HJ. Basal cell skin
cancer after total-body irradiation and hematopoietic cell transplantation. Radiat Res 171(155163):155-163, 2009. PMID not assigned yet. PMID: 19267540
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11. Bernstein SH, Unger JM, LeBlanc M, Friedberg J, Miller TP, Fisher RI. Natural history of CNS
relapse in patients with aggressive non-Hodgkin's lymphoma: a 20-year follow-up analysis of
SWOG 8516--the Southwest Oncology Group. J Clin Oncol 27(1):114-119, 2009. PMID:
19047289
12. Donaldson GW, Nakamura Y, Moinpour C. Mediators, moderators, and modulators of causal
effects in clinical trials--dynamically modified outcomes (DYNAMO) in health-related quality of
life. Qual Life Res 18:137-145, 2009. PMID: 19152118
13. Moinpour CM, Donaldson GW, Nakamura Y. Chemotherapeutic impact on pain and global
health-related quality of life in hormone-refractory prostate cancer: dynamically modified
outcomes (DYNAMO) analysis of a randomized controlled trial. Qual Life Res 18:147-155, 2009.
PMID: 19130298
14. Rubenstein L, Crowley J, Ivy P, LeBlanc M, Sargent D. Randomized Phase II designs. Clin
Cancer Res 15(6):1883-1890, 2009. PMID: 19276275
15. Hershman DL, Unger JM, Barlow WE, Hutchins LF, Martino S, Osborne CK, Livingston RB,
Albain KS. Treatment quality and outcomes of African American versus white breast cancer
patients: retrospective analysis of Southwest Oncology Group studies S8814/S8897. J Clin
Oncol 27(13):2157-2162, 2009. PMID: 19307504
16. Stopeck AT, Unger JM, Rimsza LM, Bellamy WT, Iannone M, Persky DO, LeBlanc M, Fisher RI,
Miller TP. A Phase III trial of single agent bevacizumab in patients with relapsed, aggressive
Non-Hodgkin lymphoma: Southwest Oncology Group study S0108. Leuk Lymphoma 50(5):728735, 2009. PMID: 19373598
17. Heinrich MC, Owzar K, Corless CL, Hollis D, Borden EC, Fletcher CDM, Ryan CW, von Mehren
M, Blanke CD, Rankin C, Benjamin RS, Bramwell VH, Demetri GD, Bertagnolli MM, Fletcher JA.
Correlation of kinase genotype and clinical outcome in the North American Intergroup Phase III
trial of imatinib mesylate for treatment of advanced gastrointestinal stromal tumor: CALGB
150105 study by Cancer and Leukemia Group B and Southwest Oncology Group. J Clin Oncol
26(33):5360-5367, 2009. PMID: 18955451
18. Koreth J, Schlenk R, Kopecky K, Honda S, Sierra J, Djulbegovic B, Wadleigh M, DeAngelo D,
Stone R, Sakamaki H, Appelbaum F, Döhner H, Antin J, Soiffer R, Cutler C. Allogeneic stem cell
transplantation for acute myeloid leukemia in first complete remission: systematic review and
meta-analysis of prospective clinical trials. JAMA 301(22):2349-2361, 2009. PMID: 19509382
19. Lara PN, Jr, Natale R, Crowley J, Lenz H-J, Redman MW, Carleton JE, Jett J, Langer CJ,
Kuebler JP, Dakhil SR, Chansky K, Gandara DR. Phase III trial of irinotecan/cisplatin compared
with etoposide/cisplatin in extensive-stage small-cell lung cancer: clinical and
pharmacogenomic results from SWOG S0124. J Clin Oncol 27(15):2530-2535, 2009. PMID:
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20. Le Q-TX, Moon J, Redman M, Williamson SK, Lara PN, Jr, Goldberg Z, Gaspar LE, Crowley JJ,
Moore DF, Jr, Gandara DR. Phase II study of tirapazamine, cisplatin, and etoposide and
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21. LeBlanc M, Rankin C, Crowley J. Multiple histology Phase II trials. Clin Cancer Res 15(13):42564262, 2009. PMID: 19549777
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23. Albain KS, Unger JM, Crowley JJ, Coltman CA, Jr, Hershman DL. Racial disparities in cancer
survival among randomized clinical trials patients of the Southwest Oncology Group. J Natl
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24. Hussain M, Goldman B, Tangen C, Higano CS, Petrylak DP, Wilding G, Akdas AM, Small EJ,
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progression predicts overall survival in patients with metastatic prostate cancer: data from
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27(15):2450-2456, 2009. PMID: 19380444
25. Hussein MA, Bolejack V, Zonder JA, Durie BGM, Jakubowiak AJ, Crowley JJ, Barlogie B. Phase
II study of thalidomide plus dexamethasone induction followed by tandem melphalan-based
autotransplantation and thalidomide-plus-prednisone maintenance for untreated multiple
myeloma: a Southwest Oncology Group Trial (S0204). J Clin Oncol 27(21):3510-3517, 2009.
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26. deVere White RW, Lara PN, Jr, Goldman B, Tangen CM, Smith DC, Wood DP, Jr, Hussain
MHA, Crawford ED. A sequential treatment approach to myoinvasive urothelial cancer: a Phase
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28. Smith HO, Moon J, Wilcyznski SP, Tiersten AD, Hannigan EV, Robinson WR, Rivkin SE,
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primary chemotherapy of small-volume residual stage III ovarian cancer. Gynecol Oncol
114:206-209, 2009. PMID: 19464730
29. Yoo GH, Moon J, LeBlanc M, Lonardo F, Urba S, Kim H, Hanna E, Tsue T, Valentino J, Ensley
J, Wolf G. A Phase II trial of surgery with perioperative INGN 201(Ad5CMV-p53) gene therapy
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30. Whitehead RP, Rankin C, Hoff PMG, Gold PJ, Billingsley KG, Chapman RA, Wong L, Ward JH,
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31. Tiersten AD, Liu P-Y, Smith HO, Wilcyznski SP, Robinson WR, III, Markman M, Alberts DS.
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32. Lerner SP, Tangen CM, Sucharew H, Wood D, Crawford ED. Failure to achieve a complete
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33. Sonpavde G, Goldman JH, Speights VO, Lerner SP, Wood DP, Vogelzang NJ, Trump DL,
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34. Thompson IM, Tangen CM, Paradelo J, Lucia MS, Miller G, Troyer D, Messing E, Forman J,
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36. Davies AM, Chansky K, Lara PN, Jr, Gumerlock PH, Crowley J, Albain KS, Vogel SJ, Gandara
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37. Dhodapkar DV, Hoering A, Gertz MA, Rivkin S, Szymonifka J, Crowley J, Barlogie B. Long-term
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38. Thompson IM, Tangen CM, Goodman PJ, Lucia MS, Klein EA. Chemoprevention of prostate
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40. Crawford ED, Tangen CM. Clinical integration: laudable, but challenging. Nat Rev Urol 6(6):297298, 2009. PMID: 19498403
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41. Dai JY, LeBlanc M, Smith NL, Psaty B, Kooperberg C. SHARE: an adaptive algorithm to select
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50. Schenk JM, Kristal AR, Neuhouser ML, Tangen CM, White E, Lin DW, Thompson IM. Serum
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55. Tangen CM, Goodman PJ. Prostate-specific antigen and its role on the Prostate Cancer
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59. Tangen CM, Goldman B, Swanson G, Thompson IM. Biased hormonal therapy analysis makes
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60. Platz EA, Lippman SM. Selenium, genetic variation, and prostate cancer risk: epidemiology
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63. Klein EA. The Selenium and Vitamin E Cancer Prevention Trial. In Prostate Cancer Screening,
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64. Van Veldhuizen PJ, Hussey M, Lara PN, Mack PC, Gandour-Edwards R, Clark JI, Lange MK,
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Quinn DI, Pan CX, Crawford DE. A phase II study of erlotinib (OSI-774) in patients with locally
advanced or metastatic papillary histology renal cell cancer SWOG S0317. In: Journal of Clinical
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66. Dorff TB, Tangen CM, Crawford ED, Petrylak DP, Higano CS, Raghavan D, Quinn DI,
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68. Okunieff P, Kachnic A, Fuller CD, Gaspar LE, Hayes DF, Hooks J, Ling C, Meyskens Jr FL,
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Fitch TR, Goldberg RM, Alberts SR. A randomized phase III non-inferiority trial of irinotecan
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1. Beer TM, Goldman B, Synold TW, Ryan CW, Vasist LS, Van Veldenhuizen PJ, Jr, Dakhil SR,
Lara PN, Jr, Drelichman A, Hussain MHA, Crawford ED. Southwest Oncology Group phase II
study of ispinesib in androgen-independent prostate cancer previously treated with taxanes. Clin
Genitourin Cancer 6(2):103-109, 2008. PMID: 18824433
2. Chew HK, Barlow WE, Albain K, Lew D, Gown A, Hayes DF, Gralow J, Hortobagyi GN,
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cancer: Southwest Oncology Group study 0338. Clin Breast Cancer 8(6):511-515, 2008. PMID:
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3. Mack P, Redman M, Chansky K, Williamson S, Farneth N, Lara PN, Jr, Franklin WA, Le Q-T,
Crowley JJ, Gandara D. Lower osteopontin plasma levels are associated with superior outcomes
in advanced non-small-cell lung cancer patients receiving platinum-based chemotherapy:
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4. Moore SR, Persons DL, Sosman JA, Bobadilla D, Bedell V, Smith DD, Wolman SR, Tuthill RJ,
Moon J, Sondak VK, Slovak ML. Detection of copy number alterations in metastatic melanoma
by a DNA fluorescence in situ hybridization probe panel and array comparative genomic
hybridization: a Southwest Oncology Group study (S9431). Clin Cancer Res 14(10):2927-2935,
2008.
5. Misono S, Weiss NS, Fann JR, Redman M, Yueh B. Incidence of suicide in persons with cancer.
J Clin Oncol 26(29):4731-4738, 2008. PMID: 18695257
6. Borden EC, Kluger H, Crowley J. Apoptosis: a clinical perspective. Nat Rev Drug Discov
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7. Shepherd BF, Redman MW, Ankerst DP. Does finasteride affect the severity of prostate cancer?
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genes with abnormal expression changes in acute myeloid leukemia. Genes Chromosomes
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9. Moinpour CM, Hayden KA, Unger JM, Thompson IM, Jr, Redman MW, Canby-Higano ED,
Higgins BA, Sullivan JW, Lemmon D, Breslin S, Crawford ED. Health-related quality of life
results in pathologic stage C prostate cancer from a Southwest Oncology Group trial comparing
radical prostatectomy alone with radical prostatectomy plus radiation therapy. J Clin Oncol
26(1):112-120, 2008. PMID: 18165645
10. Lara PN, Jr, Redman MW, Kelly K, Edelman MJ, Williamson SK, Crowley JJ, Gandara DR.
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results from Southwest Oncology Group randomized trials. J Clin Oncol 26(3):463-467, 2008.
PMID: 18202421
Korn EL, Liu P-Y, Lee SJ, Chapman JW, Niedzwiecki D, Suman VJ, Moon J, Sondak VK, Atkins
MB, Eisenhauer EA, Parulekar W, Markovic SN, Saxman S, Kirkwood JM. Meta-analysis of
phase II cooperative group trials in metastatic stage IV melanoma to determine progression-free
and overall survival benchmarks for future phase II trials. J Clin Oncol 26(4):527-534, 2008.
PMID: 18235113
Swinnen LJ, Rankin C, Carraway H, Albain KS, Townsend JJ, Budd GT, Kish JA, Rivkin SE,
Blumenthal DT. A Phase III study of cisplatin preceded by a 12-h continuous infusion of
concurrent hydroxyurea and cytosine arabinoside (Ara-C) for adult patients with malignant
gliomas (Southwest Oncology Group S9149). J Neurooncol 86:353-358, 2008. PMID: 18175205
Pullarkat V, Slovak ML, Kopecky KJ, Forman SJ, Appelbaum FR. Impact of cytogenetics on the
outcome of adult acute lymphoblastic leukemia: results of Southwest Oncology Group 9400
study. Blood 111(5):2563-2572, 2008. PMID: 18156492
Goldman B, LeBlanc M, Crowley J. Interim futility analysis with intermediate endpoints. Clin
Trials 5:14-22, 2008. PMID: 18283075
Mok TSK, Crowley J. Big question, small answer. J Thorac Oncol 3(2):105-106, 2008. PMID:
18303427
Ganz PA, Hussey MA, Moinpour CM, Unger JM, et al. Late cardiac effects of adjuvant
chemotherapy in breast cancer survivors treated on Southwest Oncology Group protocol S8897.
J Clin Oncol 26(8):1223-1230, 2008. PMID: 18227530
Davis S, Onstad L, Kopecky KJ, Wiggins C, Hamilton TE. Locating members of a cohort
identified retrospectively from limited data in 50-year-old records: Successful approaches
employed by the Hanford Thyroid Disease study. Ann Epidemiol 18(3):187-195, 2008. PMID:
18201901
Matsui S, Yamanaka T, Barlogie B, Shaughnessy JJ, Crowley J. Clustering of significant genes
in prognostic studies with microarrays: application to a clinical study for multiple myeloma. Stat
Med 27:1106-1120, 2008. PMID: 17680552
Goodwin JW, Green SJ, Moinpour CM, Bearden JD, III, Giguere JK, Jiang CS, Lippman SM,
Martino S, Albain KS. Phase III randomized placebo-controlled trial of two doses of megestrol
acetate as treatment for menopausal symptoms in women with breast cancer: Southwest
Oncology Group study 9626. J Clin Oncol 26(10):1650-1656, 2008. PMID: 18375894
Flaig TW, Tangen CM, Hussain MHA, Stadler WM, Raghavan D, Crawford ED, Glodé LM.
Randomization reveals unexpected acute leukemias in Southwest Oncology Group prostate
cancer trial. J Clin Oncol 26(9):1532-1536, 2008. PMID: 18349405
Hamilton TE, Davis S, Onstad L, Kopecky KJ. Thyrotropin levels in a population with no clinical,
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27. Blumenthal DT, Rankin C, Eyre HJ, Livingston RB, Spence AM, Stelzer KJ, J RE, Berger MS,
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38. Allegra C, Benedetti JK. Don Quixote and the quest for personalized medicine. J Clin Oncol
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Wolf MS, Bennett CL. Local perspective of the impact of the HIPAA privacy rule on research.
Cancer 106(2):474-479, 2006. PMID: 16342254
Caban-Holt AM, Schmitt FA, Runyons CR, Kryscio RJ, Mendiondo MS, Healey MS, Markesbery
WR, Coltman CA, Crowley JJ, Goodman PJ, Hartline JL. Studying the effects of vitamin E and
selenium for Alzheimer’s disease prevention: the PREADVISE model. In: Research and
Practice In Alzheimer’s Disease Volume 11, 2006, Vellas B, Fitten LJ, Winblad B, Feldman H,
Grundman M, Giacobini E eds, Serdi Publishers 124-130, 2006.
Worden FP, Moon J, Samlowski W, Clark JI, Dakhil SR, Williamson S, Urba SG, Ensley J,
Hussain MH. A phase II evaluation of a 3-hour infusion of paclitaxel, cisplatin, & 5-fluorouracil in
patients with advanced or recurrent squamous cell carcinoma of the head & neck: Southwest
Oncology Group study 0007. In: Cancer 107(2):319-327, 2006. PMID: 16779801
Hesketh PJ, Chansky K, Lau DH, Doroshow JH, Moinpour C, Chapman RA, Goodwin JW, Gross
HM, Crowley J, Gandara DR. Sequential vinorelbine and docetaxel in advanced non-small cell
lung cancer patients age 70 and older and/or with a performance status of 2: a phase II trial of
the Southwest Oncology Group (S0027). In: Journal of Thoracic Oncology 1(6):537-544, 2006.
PMID: 17409914
Williamson SK, McCoy SA, Gandara DR, Dakhil SR, Yost KJ, Paradelo JC, Atkins JN, Blanke
CD, Abbruzzese JL. Phase II trial of gemcitabine plus irinotecan in patients with esophageal
cancer. a Southwest Oncology Group (SWOG) trial. American Journal of Clinical Oncology
29(2):116-122, 2006. PMID: 16601427
Whitehead RP, McCoy S, Rivkin SE, Gross HM, Conrad ME, Doolittle GC, Wolff RA, Goodwin
JW, Dakhil SR, Abbruzzese JL. A phase II trial of epothilone B analogue BMS-247550 (NSC
#710428) ixabepilone, in patients with advanced pancreas cancer: a Southwest Oncology
Group study. In: Investigational New Drugs 24:515-520, 2006.
West HL, Franklin WA, McCoy J, Gumerlock P, Vance R, Lau DHM, Chansky K, Crowley JJ,
Gandara DR. Gefitinib therapy in advanced bronchioloalveolar carcinoma: Southwest Oncology
Group study S0126. In: Journal of Clinical Oncology 24(12):1807-1813, 2006.
Zonder JA, Barlogie B, Durie BGM, McCoy J, Crowley J, Hussein MA. Thrombotic complications
in patients with newly diagnosed multiple myeloma treated with lenalidomide and
dexamethasone: benefit of aspirin prophylaxis. In: Blood (Letter to the Editor) 108:403, 2006.
PMID: 16790586
Meyerhardt JA, Heseltine D, Niedzwiecki D, Hollis D, Saltz LB, Mayer RJ, Thomas J, Nelson H,
Whittom R, Hantel A, Schilsky RL, Fuchs CS. Impact of physical activity on cancer recurrence
and survival in patients with stage III colon cancer: findings from CALGB 89803. In: Journal of
Clinical Oncology 24(22): 3535-3541, 2006. PMID: 16822843
Winter JN, Weller EA, Horning SJ, Krajewska M, Variakojis D, Habermann TM, Fisher RI, Kurtin
PJ, Macon WR, Chhanabhai M, Felgar RE, His ED, Medeiros LJ, Weick JK, Reed JC, Gascoyne
RD. Prognostic significance of Bcl-6 protein expression in DLBCL treated with CHOP or RCHOP: a prospective correlative study. In: Blood 107(11):4207-4213, 2006. PMID: 16449523
Habermann TM, Weller EA, Morrison VA, Gascoyne RD, Cassileth PA, Cohn JB, Dakhil SR,
Woda B, Fisher RI, Peterson BA, Horning SJ. Rituximab-CHOP versus CHOP alone or with
maintenance rituximab in older patients with diffuse large B-cell lymphoma. In: Journal of Clinical
Oncology, 24(19):3121-3127, 2006.PMID: 16754935
Trimble CL, Kauderer J, Zaino R, Silverberg S, Lim PC, Burke JJ, Alberts DS, Curtin J.
Concurrent endometrial carcinoma in women with a biopsy diagnosis of atypical endometrial
hyperplasia: A Gynecologic Oncology Group Study. In: Cancer 106(4):812-819, 2006.
PMID: 16400639
2011
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59. Yan M, Kanbe E, Peterson LF, Boyapati A, Miao Y, Wang Y, Chen IM, Chen Z, Rowley JD,
Willman CL, Zhang DE. A previously unidentified alternatively spliced isoform of t(8;21)
transcript promotes leukemogenesis. Nature Medicine 12(8):945-949, 2006. PMID: 16892037
60. Appelbaum FR, Gundacker H, Head DR, Slovak ML, Willman CL, Godwin JE, Anderson JE,
Petersdorf SH. Age and acute myeloid leukemia. In: Blood 107(9):3481-3485, 2006.
PMID: 16455952
61. Sondak VK, Sabel MS, Mule JJ. Allogeneic and autologous melanoma vaccines: where have
we been and where are we going? In: Clinical Cancer Research 12(7 Suppl):2337s-2341s,
2006. PMID: 16609055
62. Appelbaum FR, Kopecky KJ, Tallman MS, Slovak ML, Gundacker HM, Kim HT, Dewald GW,
Kantarjian HM, Pierce SR, Estey EH. The clinical spectrum of adult acute myeloid leukaemia
associated with core binding factor translocations. In: British Journal of Haematology 135:165173, 2006. PMID: 16939487
63. Radich JP, Dai H, Mao M, Oehler V, Schelter J, Druker B, Sawyers C, Shah N, Stock W,
Willman CL, Friend S, Linsley PS. Gene expression changes associated with progression and
response in chronic myeloid leukemia. Proc of the National Academy of Sciences 103(8):27942799, 2006. PMID: 16477019
64. Wilson CS, Davidson GS, Martin SB, Andries E, Potter J, Harvey R, Ar K, Xu Y, Kopecky KJ,
Ankerst DP, Gundacker H, Slovak ML, Mosquera-Caro M, Chen IM, Stirewalt DL, Murphy M,
Schultz FA, Kang H, Wang X, Radich JP, Appelbaum FR, Atlas SR, Godwin J, Willman CL.
Gene expression profiling of adult acute myeloid leukemia identifies novel biologic clusters for
risk classification and outcome prediction. In: Blood 108(2):685-696, 2006. PMID: 16597596
65. Slovak ML, Gundacker H, Bloomfield CD, Dewald G, Appelbaum FR, Larson RA, Tallman MS,
Bennett JM, Stirewalt DL, Meshinchi S, Willman CL, Ravindranath Y, Alonzo TA, Carroll AJ,
Raimondi SC, Heerema NA. Letter to the editor: A retrospective study of 69 patients with
t(6;9)(p23;q34) AML emphasizes the need for a prospective, multicenter initiative for rare ‘poor
prognosis’ myeloid malignancies. In: Leukemia 20:1295-1297, 2006. PMID: 16628187
66. Roberts RA, Wright G, Rosenwald AR, Jaramillo MA, Grogan TM, Miller TP, Frutiger Y, Chan
WC, Gascoyne RD, Ott G, Muller-Hermelink HK, Staudt LM, Rimsza LM. Loss of major
histocompatibility class II gene and protein expression in primary mediastinal large B-cell
lymphoma is highly coordinated and related to poor patient survival. In: Blood 108(1):311-318,
2006. PMID: 16543468
67. Dave SS, Fu K, Wright GW, Lam LT, Kluin P, Boerma EJ, Greiner TC, Weisenburger DD,
Rosenwald A, Ott G, Muller-Hermelink HK, Gascoyne RD, Delabie J, Rimsza LM, Braziel RM,
Grogan TM, Campo E, Jaffe ES, Dave BJ, Sanger W, Bast M, Vose JM, Armitage JO, Connors
JM, Smeland EB, Kvaloy S, Holte H, Fisher RI, Miller TP, Montserrat E, Wilson WH, Bahl M,
Zhao H, Yang L, Powell J, Simon R, Chan WC, Staudt LM. Molecular diagnosis of Burkitt‘s
lymphoma. In: New England Journal of Medicine 354(23): 2431-2442, 2006. PMID: 16760443
68. Greiner TC, Dasgupta C, Ho VV, Weisenburger DD, Smith LM, Lynch JC, Vose JM, Fu K,
Armitage JO, Braziel RM, Campo E, Delabie J, Gascoyne RD, Jaffe ES, Muller-Hermelink HK,
Ott G, Rosenwald A, Staudt LM, Im MY, Karaman MW, Pike BL, Chan WC, Hacia JG. Mutation
and genomic deletion status of ataxia telangiectasia mutated (ATM) and p53 confer specific
gene expression profiles in mantle cell lymphoma. In: Proc of the National Academy of Sciences
103(7):2352-2357, 2006. PMID: 16461462
69. Pabst T, Stillner E, Neuberg D, Nimer S, Willman CL, List AF, Melo JV, Tenen DG, Mueller BU.
Mutations of the myeloid transcription factor CEBPA are not associated with the blast crisis of
chronic myeloid leukaemia. In: British Journal of Haematology 133:400-402, 2006.
PMID: 16643447
70. Stirewalt DL, Kopecky KJ, Meshinchi S, Engel JH, Pogosova-Agadjanyan EL, Linsley J, Slovak
ML, Willman CL, Radich JP. Size of FLT3 internal tandem duplication has prognostic
significance in patients with acute myeloid leukemia. In: Blood 107(9):3724-3726, 2006.
PMID: 16368883
71. Haarer CF, Roberts RA, Frutiger YM, Grogan TM, Rimsza LM. Immunohistochemical
classification of de novo, transformed, and relapsed diffuse large B-cell lymphoma into germinal
center B-cell and non-germinal center B-cell subtypes correlates with gene expression profile
and patient survival. In: Archives of Pathology & Laboratory Medicine 130:1819-1824, 2006.
PMID: 17149956
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72. Miller TP, Spier CM, Rimsza L. Diffuse aggressive histologies of non-Hodgkin lymphoma:
treatment and biology of limited disease. In: Seminars in Hematology 43:207-212, 2006.
PMID: 17027654
73. Unger JM, Coltman Jr CA, Crowley JJ, Hutchins LF, Martino S, Livingston RB, Macdonald JS,
Blanke CD, Gandara DR, Crawford ED, Albain KS. Impact of the year 2000 medicare policy
change on older patient enrollment to cancer clinical trials. In: Journal of Clinical Oncology
24(1):141-144, 2006. PMID: 16330670
74. Unger JM, Green SR, Albain KS. Outcome of African American women with breast cancer in
cooperative Group clinical trials. In: Breast Cancer In Women of African Descent. The
Netherlands: Springer, Chapter 11, pp 267-295, 2006.
75. Lao CD, Demierre MF, Sondak VK. Targeting events in melanoma carcinogenesis for the
Prevention of melanoma. Expert Reviews in Anticancer. In: Therapy 6(11):1559-1568, 2006.
PMID: 17134361
Leadership and Service in Cancer, Clinical Trials, and Statistics
SWOG statisticians provide leadership and expertise on the national and international level to other
research and professional organizations through service that in turn enriches and strengthens the
activities at the Statistical Center. Recent examples of these activities are:
Review / Advisory panels
2011
Member (ad hoc), NIH Biomedical Computing and Health Informatics Study Section
(W Barlow)
2010–present
Member, Thoracic Malignancies Steering Committee (J Crowley)
2010–present
Reviewer, European Commission for Medical Research (A Hoering)
2010
Reviewer, POCRC Developmental Research Program (G Anderson)
2010
Chair, Special Emphasis Panel; NCI Review Committee (W Barlow)
2010
Panel member, NIH State-of-the-Science Conference: Enhancing Use and Quality
of Colorectal Cancer Screening (W Barlow)
2010
ASCO panel, revision of Guidelines for Bisphosphonates in Metastatic Breast
Cancer (W Barlow)
2009–present
Member, Cancer Prevention Research in Texas, Translational Research Review
Committee (W Barlow)
2009–present
Member, American Cancer Society, – Cancer Control and Prevention section review
(W Barlow)
2009–present
Reviewer, National Cancer Institute (A Hoering)
2009–present
Member, Molecular Modeler Working Group, American Joint Committee on Cancer
(M LeBlanc)
2008–present
Member, Gynecological Cancer International Group (G Anderson)
2008–present
Member, Gynecological Cancer Steering Committee and Ovarian Task Force (G
Anderson)
th
2008–2009
Panel member, AJCC Cancer Staging, 7 Edition, Breast Chapter (W Barlow)
2008–2009
Member, Planning Committee, National Cancer Institute, Diagnosis and
Management of Ductal Carcinoma In Situ conference (W Barlow)
2007–2010
Charter Member NIH Health Services Organization and Delivery Study Section (W
Barlow)
2007–2010
Member NIH Health Services Organization and Delivery Study Section (W Barlow)
2007–present
Member, Symptom Management and Health-Related Quality of Life Steering
Committee, National Cancer Institute Clinical Trials Restructuring Initiatives (C
Moinpour)
2007–present
Member, External Advisory Committee, Cancer Prevention Trials Unit, Cancer
Research UK (J Crowley)
2007
Reviewer, NIH, SUBCOMMITTEE F - MANPOWER & TRAINING
(M LeBlanc)
2007
Co-chair, SPORE Preconference Workshop: Strategies for implementing biomarker
evidence in translational cancer research (G Anderson)
2006–present
Member, International Myeloma Foundation Scientific Advisory Board (J Crowley)
August
2011
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SWOG STATISTICAL CENTER
2006–2011
2006–2010
2006
2006
2006
2006
Member, NCI Subcommittee H (Chair 2010-2011)—Cooperative
Groups (J Benedetti)
Member, Advisory Board, FHCRC Survivorship Center, Lance Armstrong
Foundation Network of Survivorship Center (C Moinpour)
Member, VA cooperative Studies Program Review Committee (J Crowley)
Member, Cardiovascular Strategic Planning Level 1: Clinical Trial Design, NHLBI (G
Anderson)
ASCO Chair of Statistical Track for Program committee (J Benedetti)
Member, Organizing Committee for the SPORE Preconference Workshop on
Statistical Methods for Clinical Trials and Biomarkers (G Anderson)
NCI Service
Member (Ad Hoc), Special Emphasis Panel; NCI Epidemiology, Prevention Control & Population
Sciences P01 Review Committee (M LeBlanc)
Member, NCI Imaging Steering Committee (M LeBlanc)
Member, NCI Lymphoma Steering Committee (M LeBlanc)
Member, NCI Myeloma Steering Committee (A Hoering)
Member, Clinical Trials Design Task Force, Phase II (M LeBlanc)
Member, Research Evaluation Panel (Colon TMA) (J Benedetti)
Member, Breast Cancer Intergroup Committee (W Barlow)
Member, Breast Cancer Intergroup Translational Medicine Committee (W Barlow)
Member, Breast Cancer Datamart Committee (W Barlow)
Reviewer (Ad Hoc), Subcommittee H, NCI (G Anderson)
Member, Gastrointestinal Task forces (Colon, Neuroendocrine and Pancreas) (J Benedetti)
Member, Gastrointestinal Steering Committe (J Benedetti)
Member, Genitourinary Steering Committee (C Tangen)
Alternate Statistical Member, Breast Cancer Steering Committee (W Barlow)
Data and Safety Monitoring Committees
2010–present
Member, DSMB committee, University of Utah School of Medicine (A Hoering)
2010–present
Member, DSMC, Study of Cognition and Oncology and Report of Emotions
(SCORE), University of Washington (C Tangen)
2010–present
Member, Data and Safety Monitoring Board for the NIA sponsored ASPirin in
Reducing Events in the Elderly (ASPREE) funded by the NIA and Australian Health
Authority. (G Anderson)
2010–present
Chair, Data and Safety Monitoring Board for the NIA sponsored Partnership for
Anemia: Clinical and Translational Trials in the Elderly consortium (PACTTE)
2010–present
Member, NHLBI Protocol Review Committee for PROspective Multicenter Imaging
Study for Evaluation of Chest Pain (PROMISE) (G Anderson)
2008–present
Member, DSMC, Canary-EDRN Prostate Active Surveillance Study (PASS) (C
Tangen)
2008–present
Member, Data Safety and Monitoring Committee, National Surgical Breast and
Bowel Project trial B-41 (W Barlow)
2008–2011
Member, Data Monitoring Committee, North Central Cancer Treatment Group
(NCCTG) (M LeBlanc)
2008–present
Member, Data and Safety Monitoring Board for the NCI sponsored National Surgical
Adjuvant Breast and Bowel Project (NSABP) cooperative oncology group (G
Anderson)
2007–present
Effects of Aspirin in Gestation and Reproduction (G Anderson)
2006–2011
Member, Independent Data Monitoring Committee for MD Anderson Cancer Center
(M LeBlanc)
2006–present
Early Detection Research Network (J Benedetti)
2006
CMV Study, (J Benedetti)
2005–present
Member SWOG DSMC (C Tangen)
2005–present
Chair, Data Safety and Monitoring Committee, Ethiopia Trachoma Monitoring Study
(TANA), NEI, (W Barlow)
2005–present
Member, Data Safety and Monitoring Committee, Multicenter Uveitis Steroid
Treatment Trial, NEI (W Barlow)
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2011
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Literature Cited
1.
Albain KS, Crowley JJ, LeBlanc M, Livingston RB: Determinants of improved outcome in small
cell lung cancer: An analysis of the 2,580-patient SWOG database. J Clin Oncol 8:1563-1574,
1990.
2.
Albain KS, Crowley JJ, Livingston RB: Long-term survival and toxicity in small cell lung cancer:
Expanded SWOG experience. Chest 99:1425-1432, 1991.
3.
Albain KS, Crowley JJ, LeBlanc M, Livingston RB: Survival determinants in extensive stage nonsmall cell lung cancer: The SWOG experience. J Clin Oncol 9:1618-1626, 1991.
4.
Crowley J, Green S, Liu PY, Wolf M: Data monitoring committees and early stopping guidelines:
The SWOG experience. Stat Med 13:1391-1399, 1994.
5.
Dahlberg S, Fisher RI, Coltman CA, Jr.: African Americans treated on SWOG NHL studies:
similar incidence, received dose intensity, and outcome to Caucasian patients. ASCO
Proceedings 13:370(#1251), 1994.
6.
Flaherty L, Unger J, Liu PY, Albain KS, Sondak V: Gender differences and independent
predictors of survival in patients with metastatic malignant melanoma. ASCO Proceedings
15:433, 1996.
7.
Bernstein D and Lagakos SW (1978). Sample size and power determination for stratified clinical
trials. Journal of Statistical Computation Simulation 8:65-73.
8.
Fleming T, Green S, Harrington D: Considerations for monitoring and evaluating treatment
effects in clinical trials. Control Clin Trials 5:55-66, 1984.
9.
Green S, Dahlberg S: Planned vs attained design for Phase II clinical trials. Stat Med 11:853862, 1992.
10.
Hutchins L, Rector D, Stotts C, Dahlberg S, Coltman CA Jr., Albain K: Analysis of SWOG
(SWOG) accrual for sex ratios and associated socioeconomic status (SES) factors. ASCO
Proceedings 13:188 (#539), 1994. Abstract
11.
Modiano M, Villar-Werstler P, Crowley J, Salmon S: Evaluation of race as a prognostic factor in
multiple myeloma: An ancillary of SWOG study 8229. J Clin Oncol 14:974-977, 1996.
12.
Hutchins LF, Unger JM, Crowley JJ, Coltman CA Jr, Albain KS: Underrepresentation of patients
65 years of age or older in cancer treatment trials. N Engl J Med 341(27):2061-2067, 1999.
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2011
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