ABSTRACT
In the summer of 2020, there were multiple efforts to establish safe and effective vaccines that would combat the spread of COVID-19. Efforts to eradicate the virus in the United States included Operation Warp Speed (OWS) which was a partnership between the Departments of Health and Human Services (HHS) and Defense (DOD), and the private sector, that aimed to help accelerate control of the COVID-19 pandemic by advancing development, manufacturing, and distribution of vaccines, therapeutics, and diagnostics. As the nation's largest integrated healthcare system, the US Department of Veterans Affairs (VA) was identified as a potential collaborator in several large-scale OWS Phase III clinical trial efforts designed to evaluate the safety and efficacy of various vaccines in development. Given the national (and global) importance of these trials, it was recognized that there would be a need for a coordinated, centralized effort within VA to ensure that its medical centers (sites) would be ready and able to efficiently initiate, recruit, and enroll into these OWS COVID-19 vaccine trials. To accomplish this mission, two groups within the VA Office of Research and Development (ORD) partnered to manage and provide support to these sites and facilitate their execution of these trials. The Partnered Research Program (PRP) is a division of VA ORD that is dedicated to developing partnerships that enhance Veterans' access to high-quality, multi-site clinical trials. PRP has an overall goal of establishing long-term relationships with external organizations that are committed to Veterans' health and VA's clinical research mission. The VA Cooperative Studies Program (CSP) is a clinical research infrastructure embedded within the VA healthcare system. CSP is also a division of the VA ORD and was established to provide coordination for, and enable cooperation on, multi-site clinical trials and epidemiological studies that fall within the purview of VA. Its infrastructure comprises a number of Coordinating Centers that are responsible for the planning and conduct of large multi-site clinical trials in the VA healthcare system. CSP also established a consortium of 10 VA medical centers (VAMCs) called the Network of Dedicated Enrollment Sites (NODES) that have teams (nodes) to provide site-level expertise and innovative approaches in addressing challenges to clinical trial execution. This (poster) outlines the partnership and activities undertaken by VA's PRP and CSP NODES groups to manage and support a large-scale OWS Phase III multi-site clinical trial. It focuses specifically on the determination to designate clinical trial facilitators to study sites, the important role that they played in getting this trial initiated at those sites in a timely fashion, and their work to ensure successful study enrollment.