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

> **NIH NIH U24** · VANDERBILT UNIVERSITY MEDICAL CENTER · 2020 · $1,403,857

## Abstract

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 protocol
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 an 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, RecordCounter, REDCap9,TrialFinder, and SubjectLocater) 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
enha...

## Key facts

- **NIH application ID:** 10158963
- **Project number:** 3U24TR001579-05S1
- **Recipient organization:** VANDERBILT UNIVERSITY MEDICAL CENTER
- **Principal Investigator:** Paul A. Harris
- **Activity code:** U24 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $1,403,857
- **Award type:** 3
- **Project period:** 2016-07-01 → 2023-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10158963

## Citation

> US National Institutes of Health, RePORTER application 10158963, Improving Clinical trial Education, Recruitment, and Enrollment at CTSA Hubs (I-CERCH) (3U24TR001579-05S1). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10158963. Licensed CC0.

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