Improving Clinical trial Education, Recruitment, and Enrollment at CTSA Hubs (I-CERCH)

A recent analysis shows that nearly 1 in 5 clinical trials either terminated for failed participant accrual, or completedwith <85% of the expected enrollment. These recruitment challenges ultimately reduce the speed with whichadvances in medicine reach the general population. Recruitment strategies should at the forefront of protocoldevelopment discussions; however, clinical research teams often discuss recruitment strategies only after crudepatient estimates suggest feasibility, and after a study protocol has been written, approved by an IRB, and is readyto enroll the first patient. Not surprisingly, study coordinators then find themselves with thedifficult 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 transformthe research recruitment and enrollment landscape. We propose a set of innovative, integrated solutions torecruitment and enrollment challenges that accommodate real ethical, regulatory, legal, practical, and technicalconstraints 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 everystage of recruitment: foundational recruitment education, study cohort identification and estimation, communityengagement, pre-screening, informed consent, enrollment and retention monitoring, and returning of researchresults. Underlying our solutions will be a national, disease-neutral and informatics supported system that supportsenrollment for individual trials. We will build upon existing recruitment and data tools and resources already in useby our team and others (e.g. ResearchMatch8, RecordCounter, REDCap9,TrialFinder, and SubjectLocater) toassemble a sophisticated informatics-based recruitment infrastructure. The informatics infrastructure will be pairedwith study-specific support provided by recruitment specialists, customizable recruitment materials, andmeaningful community engagement. I-CERCH will be led by Paul Harris, PhD, who will serve as PI responsibleinformatics development, and Consuelo H. Wilkins, MD, MSCI, who will serve as PI of community and stakeholderengagement. 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 thecreation, storing, and sharing of recruitment education, programs, and best practices; 2) Catalyze enrollment bydeveloping and disseminating novel technical and procedural approaches to support researchers in recruitingparticipants; 3) Enhance national awareness of research through patient education, and facilitate participantidentification of studies with novel online patient facing tools; and 4) Conduct rigorous studies on methods toenhance recruitment efficacy/efficiency and make modifications based on these data.