2025 · Clinical pharmacology and therapeutics · open access
Operationalizing Decentralized Clinical Trials: Technology Insights from the Trials@Home RADIAL Proof-of-Concept Trial
Hanke et al.
The finding, in our words
The RADIAL proof-of-concept trial demonstrated that a modular, multi-vendor technology package can operationalise decentralised clinical trials, but revealed significant challenges with Bring Your Own Device variability, immature device technologies, and clinical site infrastructure limitations. Investing in participant support infrastructure, automated multichannel notifications, and early cross-functional compliance planning enhanced participant engagement and streamlined governance, reducing burden.
A paraphrase to the Library’s standard, never the abstract. The source is one link away and is always the authority.
The study observed favourable trends in the accrual of participants residing far from the site and those from underrepresented groups following the implementation of a decentralised clinical trial program.
A fully remote decentralised clinical trial in Danish adults with type 2 diabetes demonstrated operational feasibility with rapid recruitment, high retention (87 percent), and excellent adherence to continuous glucose monitoring (95 percent achieving ≥70 percent data coverage) and telemedicine visits (97 percent). Activity tracker adherence was poor (12 percent) due to technical issues, but remote safety monitoring was effective with no unexpected adverse events, supporting the viability of remote diabetes management.
Viloxazine extended release improved ADHD, depression and anxiety symptoms in adults with comorbid conditions during a 14-week decentralised trial. The study demonstrates that remote monitoring via televisit, mobile app and home devices can deliver real-world efficacy and safety data for psychiatric medications.
Adler et al., The Journal of clinical psychiatry (paywalled) · source ↗
A proof-of-concept decentralised trial generated 169 support tickets over 17 months from 90% of sites, with device-related problems accounting for 46% of requests. Most issues were resolved within three days and required two to six exchanges, demonstrating that robust technical support infrastructure is essential for successful remote monitoring and wearable-based trial conduct.
Weitlaner et al., Journal of medical systems · source ↗
A hybrid decentralised clinical trial using wearable dosing-monitoring and remote adverse-event reporting in healthy adults achieved 100% adherence with only 2% missing data, maintained adverse-event detection sensitivity, and was rated less burdensome than conventional on-site visits. These findings support the feasibility and reliability of participant-centric remote monitoring in early-phase pharmacokinetic studies.
Kim et al., Clinical and translational science · source ↗