A recent analysis shows that nearly 1 in 5 clinical trials either terminated for failed participant accrual, or completed with <85% of the expected enrollment. These recruitment challenges ultimately reduce the speed with which advances in medicine reach the general population. Recruitment strategies should at the forefront of development discussions; however, clinical research teams often discuss recruitment strategies only after crude patient estimates suggest feasibility, and after a study protocol has been written, approved by a IRB, and is ready to enroll the first patient. Not surprisingly, study coordinators then find themselves with the difficult task of recruiting patients who meet narrow inclusion criteria, and retaining participants through numerous (sometimes onerous) study visits. The Recruitment Innovation Center program has the potential to truly transform the research recruitment and enrollment landscape. We propose a set of innovative, integrated solutions to recruitment and enrollment challenges that accommodate real ethical, regulatory, legal, practical, and technical constraints faced by investigators. These will be available through the Improving Clinical Trial Education, Recruitment and Enrollment at CTSA Hubs (I-CERCH) Center. Solutions will be available to investigators for every stage of recruitment: foundational recruitment education, study cohort identification and estimation, community engagement, pre-screening, informed consent, enrollment and retention monitoring, and returning of research results. Underlying our solutions will be a national, disease-neutral and informatics-supported system that supports enrollment for individual trials. We will build upon existing recruitment and data tools and resources already in use by our team and others (e.g. ResearchMatch8, Record Counter, REDCap9, Trial Finder, and Subject Locater) to assemble a sophisticated informatics-based recruitment infrastructure. The informatics infrastructure will be paired with study-specific support provided by recruitment specialists, customizable recruitment materials, and meaningful community engagement. I-CERCH will be led by Paul Harris, PhD, who will serve as PI responsible informatics development, and Consuelo H. Wilkins, MD, MSCI, who will serve as PI of community and stakeholder engagement. Partnerships with 4 other CTSAs provide broad understanding of CTSA needs and key expertise.
The specific aims of the program are as follows: 1) Provide a national home and collaborative `storefront' for the creation, storing, and sharing of recruitment education, programs, and best practices; 2) Catalyze enrollment by developing and disseminating novel technical and procedural approaches to support researchers in recruiting participants; 3) Enhance national awareness of research through patient education, and facilitate participant identification of studies with novel online patient facing tools; and 4) Conduct rigorous studies on methods to enhance recruitment efficacy/efficiency and make modifications based on these data.

Public Health Relevance

A recent study showed that nearly 1 in 5 clinical trials ended early due to failure to enroll adequate numbers of study participants, or ended with less than 85% of the planned number of study participants. Ultimately, the challenge to recruiting for clinical trials slows the speed with which new treatments reach patients. We propose to provide solutions to recruitment challenges through innovative electronic health record-based tools, community engagement resources, and study-specific recruitment support that will enable researchers to implement recruitment strategies to meet their recruitment goals. Our center will be led jointly by Drs. Paul Harris and Consuelo Wilkins who will oversee an experienced, multi-disciplinary team to provide this much-needed support for clinical trial recruitment, enrollment, and retention at CTSA Hubs.

National Institute of Health (NIH)
National Center for Advancing Translational Sciences (NCATS)
Resource-Related Research Projects--Cooperative Agreements (U24)
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Special Emphasis Panel (ZTR1)
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Atkinson, Jane C
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Vanderbilt University Medical Center
United States
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Sileshi, Bantayehu; Newton, Mark W; Kiptanui, Joash et al. (2017) Monitoring Anesthesia Care Delivery and Perioperative Mortality in Kenya Utilizing a Provider-driven Novel Data Collection Tool. Anesthesiology 127:250-271