To contribute to the evidence base regarding the impact of
remote trial methods on trial efficiency and quality

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 trial methods on the quality and efficiency of clinical trials.
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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, through a grant (1UG3TR004797) from the National Center for Advancing Translational Science (NCATS), we are conducting 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 in the Buffalo and Philadelphia areas will be followed by two smaller, single-site dissemination projects: a mHealth intervention for people with depressive symptoms in the Charleston area, and an opioid overdose education and naloxone intervention in the Birmingham area. These trials harmonize 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. 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.
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This website will serve as a repository for information on all trial measures and protocols, standard academic products (conference presentations, publications), a related webinar series on remote trial methods, and, eventually, the proceedings of a national workshop on remote trial methods. These materials are intended to serve the NCATS CTSA consortium and the clinical trialist community at large