Utilization of stakeholder engagement to inform the identification of leading indicators for clinical research enrollment performance in a large integrated health care system: The VA clinical research enrollment summit.

Study participant enrollment remains the ubiquitous rate-limiter in the successful completion of clinical trials. Enrollment efficiency is a principal determinant of study performance and outcomes; and the nature of the enrolled cohort has major implications for study generalizability. Thus, all stakeholders have a role, and responsibility, in attaining enrollment targets, and each process partner has a unique vantage-point in measuring and troubleshooting enrollment barriers. The Cooperative Studies Program (CSP) is the intramural research program for multi-site clinical trials and epidemiological studies within the U.S. Department of Veterans Affairs (VA). The CSP's designated research site support infrastructure is the Network of Dedicated Enrollment Sites (NODES), which convenes annual plenary meetings to benchmark institutional performances, evaluate and update programmatic best practices, and strategize innovative approaches in clinical trial execution. The VA Clinical Research Enrollment Summit Workgroup (CREW) identifies and brings together individuals that have a vested interest in the performance of CSP and VA sponsored research (stakeholders) and this group includes representation from across CSP, invited keynote speakers, and panelists from across the VA community, yielding an evolving portrait of how clinical trialists should endeavor to motivate, manage and measure study enrollment. This manuscript focuses on the successes, challenges, and lessons learned from the VA Clinical Research Enrollment Summit Workgroup (CREW) during the development and implementation of this forum, as well as outcomes from these summits to date.