Improving Efficiency, Quality, and Equity: Randomized Controlled Evaluations of Remote vs. In-Person Clinical Trial Methods - PROJECT SUMMARY/ABSTRACT Remote trials (aka “virtual trials” or “decentralized trials”), in which patients receive treatment and provide study data without the need to travel to a clinic or medical center, have emerged as a promising approach for enhancing clinical trial efficiency. However, evidence for the hypothesized benefits of remote trials is weak, consisting primarily of anecdotal reports, uncontrolled studies, and expert opinion. The same is true for hypothesized challenges and limitations of remote trials, including concerns about technological barriers and multiple aspects of trial quality. Clearly, a stronger evidence base is needed to evaluate the impact of remote trials on the “quality and efficiency of translational research, particularly multisite trials” (CTSA Goal 4). Randomized controlled trials (RCTs) are the gold standard for comparing treatments – and, by extension, for testing the impact of remote methods on trial efficiency and quality. Accordingly, we propose an innovative, rigorous experimental evaluation of remote vs. in-person methods on trial efficiency (accrual) and quality (retention, treatment adherence, bio-specimen completion rates), across 3 RCTs on 3 different use cases: a larger, multi-site demonstration trial of pharmacotherapy for smoking cessation at the Buffalo and UPenn hubs in the UG3 Phase and two smaller, single-site dissemination projects in the UH3 Phase (a mHealth intervention for people with depressive symptoms at the MUSC hub; an opioid overdose education and naloxone intervention at the UAB hub). These trials will use a harmonized design and outcomes and follow participants through 3-month follow-up. Results from these 3 RCTs will be analyzed jointly to assess the degree to which the findings for remote vs. in-person trial methods generalize across conditions and treatment modalities. We will also explore whether use of remote versus in-person methods differentially impacts representation and retention among under-represented groups facing health disparities. The proposed series of RCTs is significant and novel in its ability to advance our understanding of the impact of remote approaches on clinical trial efficiency and rigor. The quantitative, qualitative, and cost data generated from this project will establish a translational science evidence base which will guide the design of future clinical trials. Additional dissemination efforts (e.g., project website, webinar series, conference presentations, publications, newsletters and press releases, and a national workshop) will target the CTSA consortium and clinical trialist community at large.
