Selecting and Preparing Clinical Sites for the Successful Conduct of Decentralized Clinical Trial Activities-Findings From the Trials@Home RADIAL Proof-of-Concept Trial.

ABSTRACT: Decentralized clinical trials (DCTs) offer opportunities to improve trial accessibility, participant convenience, and efficiency, yet may pose significant operational challenges for clinical trial sites. This paper presents the operational insights gained from selecting, training, and supporting clinical sites within the RADIAL proof-of-concept trial, part of the Trials@Home project. RADIAL was a multicenter, low-intervention phase IV trial comparing conventional, hybrid, and fully decentralized approaches for individuals with type 2 diabetes mellitus across six European countries. Site selection involved detailed feasibility assessments evaluating operational capabilities, recruitment potential, technological readiness, and willingness to implement decentralized elements. Despite proactiv

SUBMITTER: Lipinska K 

PROVIDER: S-EPMC12598118 | biostudies-literature | 2025 Nov

REPOSITORIES: biostudies-literature