February 2016
How One (Golden) Number
Can Transform Clinical Trials
Elisa Cascade
President Data Solutions
[email protected]
DrugDev’s Vision
DrugDev technology enables the world to do more trials through:
Industry Collaboration
TransCelerate, Investigator Databank
Standardization
DrugDev Golden Number
Beautiful Technology
Unified Platform, Intuitive UX
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DrugDev Solutions
Planning
Startup
Conduct
Closeout
Site Identification
Site Activation
Site Payments
Learning Management System
Site Engagement
Patient Engagement
Workflow Optimization
The DrugDev Golden
Number & Data Model
CTMS, EDC, IVRS,
CT.gov, Licensed
Data, etc.
System
Integrations
AP/ERP, eTMF,
Agg Spend, etc.
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DrugDev Golden Number
The Need for a Universal Identifier
Industry prepared to
collaborate, but technology
and process enhancements
were needed to realize
benefits from data sharing
Filling the gap required the
development of a universal
identifier for persons and facilities
Electronic/digital credentials
are a key step forward in
identifying a unique person,
but these credentials don’t
apply across all data sources
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Requirements for a Universal
Identifier for Persons & Facilities
High-Level
Requirements
Learnings/Process
Improvements
 Applicable to all sources of
person and facility data
 Data sources will be mapped
to one or more standard file
specifications
 Probabilistic match based on
commonly available data fields
 Importer data cleaning &
business rules
 Manual curation tools with
audit trail
 Golden facility list with 100%
facility curation
 Sequential curation process:
facilities first, then people
•
Algorithms needed to account
for missing and dirty data
 Under matching is
undesirable, but overmatching is unacceptable
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Evolution of the DrugDev
Golden Number in Operation
Sharing of
investigator/
site/protocol
data
Delivery of a
“linked” view
via the Data
Query
System
(DQS)
Integration
with the
Shared
Investigator
Platform to
index users
and facilities
Pass-back of
the DrugDev
Golden
Number for
internal data
cleaning
Coming Q3
2016: realtime access
via an API for
master data
management
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Value of the DrugDev Golden Number
•
•
•
•
•
•
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More accurate contact information
Auto-population (surveys, contracting,
payments)
Investigator/site evaluation
across all available data
Single source of the truth
De-duplicated/cleaner data
Integrated CTMS (legacy, M&A)
•
Cross-pharma sharing (e.g.,
TransCelerate, Databank)
Pharma/CRO data integration of
target/DNC lists
Investigator/facility profiles
(provided once, used by many)
•
1.
Operational
Efficiencies
3.
Collaboration
2.
Data
Mastering
4.
Integrated
Reporting
•
•
•
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Cross-vendor activity &
metrics
Consolidated view of
investigator & site activity
Financial / aggregate spend
(e.g., Sunshine)
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Quantifying the Value of the DrugDev
Golden Number to Industry: ROI Model
In collaboration with an outside consultancy, an ROI
model was developed to estimate value to industry
 Internal company interviews
 Customer interviews
 Customer beta test
Model allows tailoring to company specifics
 Number of studies, sites, patients
 Time to perform activities
 Salary associated with staff performing activities
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Quantifying the Value of the DrugDev
Golden Number to Industry: ROI Results
Reduce time spent selecting/prioritizing sites
• Potential reduction of 0-25% in time spent creating investigator lists/selecting sites (median = 10%)
Decrease the number of rescue sites needed
• 3% to 10% reduction in sites and associated start-up costs of ~$25,000 per site (median = 5%)
• 0 – 5 day savings in study timeline due to decreased need for rescue sites (median = 1 day)
Decrease IT time/costs of data cleaning/mastering
• 5% to 50% savings in time spent across studies on data cleaning/mastering (median = 20%)
Increase Investigator Engagement
• Study duration reduced by 1 – 5 days due to more engaged investigators (median = 1 days)
Median 5-year savings of ~$8M for a company with 40 studies per year,
70 sites per study, and 385 patients per study
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Benefits of the Golden Number for
Investigators & Regulators
Investigators
•
Decreased burden
•
•
•
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More focused study opportunities
Feasibility questionnaires
Site start-up documents
Data Transparency
•
Access to study-level metrics from companies providing CTMS data
Future: Health Authorities
(with company permission to share data)
• Tracking of investigator and site domain data across studies and
companies
• More robust data on the global investigator community
•
•
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Increased scope: non-US sites and studies
Historical activity: investigator vs. mean, median and SD
Facility, therapy area, & country view
• Could be used enhanced monitoring, which in turn offers the
potential to improve patient safety
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Data Sources Currently Indexed by
the DrugDev Golden Number
• CTMS data (8 large pharma & CROs)
– 2 pharma companies will on-board in Q1 2016
– 1 pharma company planned for Q2 2016
• Investigator & Facility Profiles (Investigator Databank, TransCelerate
Shared Investigator Platform)
• Network/Association membership (e.g., DrugDev Investigator
Network, ACRP)
• Public data (e.g., FDA debarment list)
• In process:
– 3rd party subscription data providers (e.g., Citeline, KarmaData)
– Identity providers (e.g., Exostar)
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Thank You!
www.drugdev.com