USING A RESEARCH REGISTRY TO RECRUIT FOR CLINICAL TRIALS
Floris Fechtel Singletary, MS, CCC-SLP
Mallorey Picone Smith, BS, CCRC
Brooks Rehabilitation: Clinical Research Center, Jacksonville, FL
BACKGROUND
METHODS
OUTCOMES
A key determinant of the success of a clinical trial is the recruitment of a study population of
an adequate size. Participant recruitment is considered by many to be the most difficult
aspect of the research process.
Low rates of recruitment result in :
• Longer durations
• Increased costs
• Less statistical power
• Questionable validity of the results
• Possible termination of the trial
In 2003 when HIPAA laws were enacted to protect human subjects’ health information, it
became necessary for researchers working within clinical settings to develop a HIPAA
compliant process to screen and potentially recruit participants for clinical trials. At Brooks
Rehabilitation Hospital we collected data on CVA admission and the ability to get authorization
to contact for research purposes from 2004 to 2010. We were successful in this endeavor as
indicated in Table 1. below. This one time authorization did not allow us to track participants
across a period of recovery and had limited information regarding diagnosis, resulting
disability and functional status. This led to the development of the Brooks Active Research
Registry (BARR).
DATA COLLECTION, TRACKING AND QUERIES POWERED BY CLINICAL CONDUCTOR
HIPPA AUTHORIZATION
RECRUITMENT POST CARDS
HIPAA Auth Total: 4165
CVA: 949
SCI: 615
BI: 652
Parkinson’s: 81
EXAMPLE:
At the end of 2013 we began to recruit participants with
a diagnosis of Parkinson’s Disease that met eligibility
criteria as described in the IRB approved flier. All
responders were then consented to the registry and
entered into Clinical Conductor. 52 participants were
recruited to the registry in 9 months for the ongoing study
as well as made accessible for future PD studies. This
process allows us to determine feasibility of new PD
studies as well as create a database from which we have
permission to contact and directly recruit.
TABLE 1.
WEB LISTINGS OF CLINICAL TRIALS
PURPOSE
ONLINE SCREENING LINKED TO CLINICAL CONCUCTOR
The Brooks Rehabilitation Clinical Research Center needed to develop a recruitment
process that included following features:
• An IRB approved process allowing for waiver of documentation of
informed consent
• The ability to recruit the same participant for multiple clinical trials
• The ability to update across a period of time
• A secure database that would coordinate with web recruitment and
consent
• A process that captured multiple recruitment venues into one
dynamic database. See Figure 1.
BARR Total: 277
CVA: 151
SCI: 26
BI: 44
Parkinson’s: 52
IRB APPROVED RECRUITMENT FLIER FOR PD COUGH/SWALLOW TRIAL
DISCUSSION
TELEPHONE SCREENING WITH VERBAL CONSENT
DIAGNOSIS SPECIFIC QUESTIONNAIRES
The infrastructure for research recruitment with BARR has proven to be a very effective
process for obtaining and maintaining a database that allows for initial entries and updates in
broad diagnostic and disability categories . The costs for the IRB, Clinical Conductor and personnel are
approximately $20,000 per year. This cost was initially supported by research infrastructure but now has
support from the revenue generated from the recruitment budgets for individual trials ($23,000 in 2013).
The success of the registry depends on the support of the various clinical sites within Brooks
Rehabilitation’s admission process . There is an ongoing need to broaden the ability to obtain
authorization or permission to contact for research purposes. We face the challenge of developing the
strategies within the clinical organization and community to inform patients about the opportunities to
participate in clinical research and subsequently build the registry partipation. We plan to further utilize the
tracking mechanisms available through Clinical Conductor to capture and analyze clinical trial success.
This work would not have been possible without the support from the administration of Brooks
Rehabilitation and the teamwork of many individuals in the admissions and marketing departments.
REFERENCES
• Marler, John R., NINDS Clinical Trials in Stroke: Lessons Learned and Future Directions.
Stroke 2007; 38:3302
• Sullivan, Jean, Subject Recruitment and Retention: Barriers to Success. Applied Clinical Trials
Online, April, 2004
• Blanton, Sarah, Morris, David, Prettyman, Michelle, et al., Lessons Learned in Participant
Recruitment and Retention : The EXCITE Trial. Physical Therapy 2006 ; 86 : 1520-1533.
• Nitkin, R. Patient recruitment strategies. Training workshop conducted by National Institutes of
Health, Bethesda, MD, 2003.
• Kernan, W., Viscoli, D., DeMarco, B., et al., Boosting enrollment in neurology trials with Local
Identification and Outreach Networks (LIONS). Neurology 2009; 71:1345-1351.
• Campbell, M. K., Snowdon, D., Francis, D. et. Al., Recruitment to randomised trials : strategies
for trial enrollment and participation study. The STEPS study. Health Technol Assess. 2007 Nov;
11 (48):iii, ix-105.
• Zerhouni, Elias. The NIH Roadmap. Science 2003; 302: 64-72.
FIGURE 1.
Waiver of Documentation of Informed Consent
45 CFR 46.117
(c) An IRB may waive the requirement for the investigator to obtain a signed consent form for
some or all subjects if it finds either:
(1) That the only record linking the subject and the research would be the consent document and
the principal risk would be potential harm resulting from a breach of confidentiality. Each subject
will be asked whether the subject wants documentation linking the subject with the research,
and the subject's wishes will govern; or
(2) That the research presents no more than minimal risk of harm to subjects and involves no
procedures for which written consent is normally required outside of the research context.
In cases in which the documentation requirement is waived, the IRB may require the investigator
to provide subjects with a written statement regarding the research.
RESEARCH REGISTRY INFORMATION SHEET CONTAINING ALL ELEMENTS OF INFORMED CONSENT
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