Toward Effective Technology Support in DCTs: Insights from the Trials@Home Proof-of-Concept Trial RADIAL

Decentralized clinical trials (DCTs) increasingly rely on digital tools such as wearable devices, mobile applications, and online platforms to enable remote data collection and participant engagement. While these technologies offer opportunities for greater convenience and continuous data capture, they also introduce operational complexity and require comprehensive technical support for participants, clinical site staff, and study teams. This paper reports on the design, implementation, use, and evaluation of a dedicated support framework in the European proof-of-concept trial RADIAL, part of the Trials@Home project, aimed at identifying effective components and operational practices for supporting DCTs. The framework included an open-source ticketing system for structured issue management, a restricted-access knowledge base (KB) with training materials and troubleshooting guides, and governance processes for escalation and quality monitoring. Key performance indicators were derived from system databases to track ticket volume, resolution times, and KB usage. Over the trial’s 17-month reporting period, 169 tickets were submitted across 90% of active clinical trial sites, with device-related problems accounting for 46% of requests and study app queries for 17%. Half of all tickets were resolved within three days, and most required two to six replies. The KB logged 696 searches and 4,350 article views, with highest engagement around training materials and device-related instructions. Findings indicate that a successful support framework for DCTs requires a combination of ticketing, accessible documentation, live support options, and continuous governance. Lessons from RADIAL underscore the importance of multilingual support, proactive training, and flexible workflows to effectively mitigate operational complexity and ensure reliable trial conduct. This trial was registered with identifier NCT05780151 in clinicaltrials.gov and under 2022-500,449-26-00 in the Clinical Trials Information System (CTIS) clinical trial database.