Development of clinical research networks in rural America: Our experience from the Accelerating COVID-19 Therapeutic Interventions and Vaccines-1 trial

Rural America remains deeply under-represented in clinical trials. St Lawrence Health (SLH) was the sole rural site and one of the top recruiters in the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV)-1 trial, which was a large international trial that studied the efficacy of three immune modulators in hospitalized patients with COVID-19. In this article, we analyze the structural and clinical factors that enabled SLH's success in the context of previously described barriers to research participation in rural areas. We conclude with lessons learned from the SLH experience and offer a broader replicable model for developing clinical research capacity in rural areas. SLH's success in ACTIV-1 can be attributed to early and sustained support from the ACTIV-1 network, a small and integrated inpatient COVID-19 treatment team, regular and consistent communication between this team and the clinical research team at SLH, and SLH's ongoing support and development of its clinical research department. SLH was, in turn, able to overcome several known barriers to implementation of clinical trials at community sites, including lack of provider time and a lack of trained research and clinical staff, and its experience in ACTIV-1 offers a replicable model for developing clinical research capacity in rural communities.