2024 · Perspectives in clinical research · open access
The role of remote data capture, wearables, and digital biomarkers in decentralized clinical trials
Chodankar et al.
The finding, in our words
The survey of 80 clinical research stakeholders in India highlights the growing adoption of remote data capture, wearables, and digital biomarkers in decentralized clinical trials, driven by the COVID-19 pandemic, while also identifying key challenges that need to be addressed for wider implementation.
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 ↗