Toward Effective Technology Support in DCTs: Insights from the Trials@Home Proof-of-Concept Trial RADIAL
Weitlaner et al.
The finding, in our words
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.
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.
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 ↗
A direct-to-participant, multichannel recruitment strategy enrolled 34,244 older adults into a virtual trial testing an Apple Watch based heart health programme with electrocardiogram and irregular rhythm notification features, achieving broad geographic and gender diversity but under-representing non-White ethnic groups.
Analysis of six studies revealed that decentralised clinical trial elements enhanced data completeness by enabling direct access to medical records, although this introduced a significant burden for data abstraction. The results suggest that decentralised approaches are not a universal solution but provide specific metrics that can help design fit-for-purpose trials.