2026 · Clinical and translational science · open access
Pioneering a Hybrid Decentralized Clinical Trial in South Korea: Assessing Feasibility, Data Integrity, and Participant Perceptions
Kim et al.
The finding, in our words
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.
A paraphrase to the Library’s standard, never the abstract. The source is one link away and is always the authority.
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 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 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.
Wearable-derived digital biomarkers have been accepted by regulatory agencies as endpoints in clinical trials for Duchenne muscular dystrophy, showing their potential to support decentralised diagnostics through patient-centric monitoring. This matters because it enables more sensitive and continuous assessment of disease progression outside clinical settings.
This study found that a decentralised approach using home-based sleep apnoea screening, heart rhythm monitoring and activity tracking in patients with atrial fibrillation is feasible, with high data completeness and low drop-out rates. The results support the use of patient-centric digital tools in decentralised trials for chronic cardiac conditions.