In the Spring of 2019, the Emory University Office of the Senior Vice President for Research contracted with Huron Consulting Group to produce an analysis that examined business processes across the life cycle of a grant. The subsequent results of the analysis reported: “Clinical trials are not consistently required to go through a formal feasibility review, resulting in significant staff time to approve and activate studies that may have a limited subject population or a low return on investment.”
As of November 1, 2021, Emory had 2,194 active clinical trials with 26,512 research subjects on-study; 36.5% have no/low enrollment. This equates to a total cost of no enrollment for Non-Federal clinical trials in FY 20 & FY 21 as $22,565,247.00. A small survey of PIs & CRCs in September 2016 reported two major enrollment barriers as a lack of study population (32.39%) and strict inclusion/exclusion criteria (26.76%). Other barriers to note included lengthy approval/submission process, studies not entered in ERMS (Emory Research Management System) as of date reviewed, and staff/resource issues.
Awareness and acknowledgement of the impact is the first step in establishing a feasibility process. A monthly report on active clinical trials by PI and by department/division is available on the OCR website, which includes reporting studies with no enrollment and those studies behind schedule for accrual (ocr.emory.edu/reports/index.html). In addition, the Emory Clinical Trials Dashboard is a software application designed to provide in-depth clinical trial data and metrics from eIRB, ERMS, and PowerTrials. This customizable dashboard also has a view with accrual to target totals – both IRB target and CTA target.
Huron recommends Emory create a robust scientific, financial, and operational feasibility process to assist with reducing the number of active studies with no or low enrollment. The goal is to be proactive and anticipate those studies that may not be successful at enrolling study participants prior to utilizing extensive resources and effort to open the study at Emory. Each department should establish their own feasibility review before submitting for initial IRB review and to Research Administration Services (RAS). Tools (e.g., SOP, assessment, checklists, and other institutional samples) are available at ocr.emory.edu, which can be customized to meet individual study team needs.
