Decentralized Clinical Trial Case Study: Five-stage Process for Recruiting and Completing a Site-less Clinical Study in Less Time and Lower Cost than Traditional Methods

Abstract

Healthcare delivery models have been thrust towards virtual care delivery, including site-less virtual clinical trial recruitment. Digital health technologies give trial participants a choice of participating from the convenience of home rather than traveling to a trial site, which can increase participant engagement and retention. In this case study, a five-stage process is illustrated in which a 1,000-patient virtual clinical trial was completed in just seven months at a cost 30% lower than traditional site-based recruitment. Participants were located, educated, and navigated through a successful multi-step virtual clinical trial for an at-home colon screening test. The locating and screening of patients were conducted via paid social media ads. Next, respondents were contacted by telephone by patient education specialists for additional screening, education, and support. Per protocol, it was confirmed that participants were scheduled for a colonoscopy with their preferred local provider. Finally, sample collection kits were sent to participants home. Overall, the trial achieved a timeline of six months from the first participant to final analysis, followed by dataset review and analysis in just five days. Among the lessons learned was that the trial was more efficiently conducted with the 83bar virtual process than relying on third-party sites and remote investigators to help with the study. Additionally, social media is the best way to find the right patients in the least amount of time.