Understanding the gap between expectations and reality in decentralized clinical trials
Jiang et al.
The finding, in our words
A 2025 review from China finds decentralised trials still far from standard practice despite the enthusiasm of regulators and industry, and names the operational gaps that keep them so: technology, oversight and data quality.
A paraphrase to the Library’s standard, never the abstract. The source is one link away and is always the authority.
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.
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.
Ma et al., Neurology and therapy (paywalled) · source ↗
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.
Hashiba et al., Danish medical journal (paywalled) · source ↗
In a Phase 1 crossover study of etrasimod, self-collected blood microsamples yielded pharmacokinetic exposures comparable to conventional venous sampling, both with and without participant practice sessions. Continuous wearable sensors concurrently enabled real-time remote monitoring of safety vital signs and electrocardiograms, demonstrating the viability of hybrid decentralised designs in early-phase clinical trials.
Malhotra et al., Clinical pharmacology and therapeutics · source ↗