Decentralized clinical trials in the trial innovation network: Value, strategies, and lessons learned

Abstract

New technologies and disruptions related to Coronavirus disease-2019 have led to expansion of decentralized approaches to clinical trials. Remote tools and methods hold promise for increasing trial efficiency and reducing burdens and barriers by facilitating participation outside of traditional clinical settings and taking studies directly to participants. The Trial Innovation Network, established in 2016 by the National Center for Advancing Clinical and Translational Science to address critical roadblocks in clinical research and accelerate the translational research process, has consulted on over 400 research study proposals to date. Its recommendations for decentralized approaches have included eConsent, participant-informed study design, remote intervention, study task reminders, social media recruitment, and return of results for participants. Some clinical trial elements have worked well when decentralized, while others, including remote recruitment and patient monitoring, need further refinement and assessment to determine their value. Partially decentralized, or “hybrid” trials, offer a first step to optimizing remote methods. Decentralized processes demonstrate potential to improve urban-rural diversity, but their impact on inclusion of racially and ethnically marginalized populations requires further study. To optimize inclusive participation in decentralized clinical trials, efforts must be made to build trust among marginalized communities, and to ensure access to remote technology.

Adapting to Decentralised Clinical Trials: Analysis of Trial Clinician's Experiences and Impacts on the Patient-Centred Experience (Preprint)

“…Remote tools and methods can improve trial efficiency and reduce burdens [44]. However, our findings echo [16], highlighting the extra burden on trial staff using DCT technologies.…”

“…Advocates for DCT tools and techniques promise that the method can alleviate patients' burdens in trials [44]. For example, [45] suggest that data collection becomes passive for patients using DCT technologies.…”

Progress toward realizing the promise of decentralized clinical trials

“…Fahey et al delved into recruitment methods for decentralized trials and argued that they may not always achieve the sociodemographic reach expected, but that a small unconditional monetary gift provided at the time of recruitment can increase recruitment efficiency at low overall cost [ 4 ]. Hanley et al, reporting the experience of National Center for Advancing Translational Sciences (NCATS)’ Trial Innovation Network, also suggest caution in assuming that decentralized trials have solved the problems of diversity in recruitment and retention – at least in their current incarnation – calling for more research on this topic [ 5 ]. To understand barriers to successful diverse and representative recruitment, it is critical to hear from potential participants in relevant communities.…”