529 Implementation of a Clinical Research Feasibility Program at an Academic Medical Center

Abstract

OBJECTIVES/GOALS: The objectives are 1) to describe the creation and implementation of a Clinical Research Feasibility Program at the University of Miami Miller School of Medicine (UMMSOM), and 2) to share early findings demonstrating its effectiveness in improving research operations which may be helpful for other academic medical centers. METHODS/STUDY POPULATION: Many clinical trials are closed prematurely because of low accrual or not being able to meet the target enrollment. The Miami CTSI and UMMSOM Executive Dean for Research office collaborated to establish the Research Feasibility Committee (RFC) focusing on clinical trial selection with upfront feasibility and recruitment planning. Program implementation included: 1) selecting faculty with successful clinical trial track records as committee members; 2) developing processes, tools, and governance; 3) feasibility pilot testing; and 4) feasibility program roll out and refinement. The feasibility review process starts with the PI/Designee completing a REDCap study intake form, followed by an administrative review to ensure completeness of the form. The RFC chair assigns reviewers for the studies. RESULTS/ANTICIPATED RESULTS: The RFC went live on September 1, 2022 reviewing industry sponsor clinical research studies. The RFC conducts a systematic feasibility assessment of the study protocol, operational requirements, enrollment barriers, institutional resources, and study budget (if available) for all applicable research studies prior to IRB submission and contract negotiation at the UMMSOM. To date, the RFC has received over 270 submissions. Based on feedback from users, the committee has made changes to improve the comprehension of questions and added questions to ensure capturing of critical information to assess study feasibility. Initial metrics suggest simply implementing the review process has decreased the number of clinical trial submissions: average number of studies per quarter was 41 pre-RFC vs 24 post RFC. DISCUSSION/SIGNIFICANCE: The development and implementation of the RFC involved many stakeholders from the research enterprise. Clear and frequent communication to the research community was a key factor in the program’s success. The next phase is assessing the impact of the RFC, such as preserving vital resources for trials more likely to be successful.