2023 · Journal of clinical and translational science · open access
From a decentralized clinical trial to a decentralized and clinical-trial-in-a-box platform: Towards patient-centric and equitable trials
Dulko et al.
The finding, in our words
The authors developed and deployed a decentralised trial platform for a Phase 2 COVID-19 study that used home-based monitoring devices and mobile applications to collect health data remotely, enabling inclusion of participants from diverse socioeconomic backgrounds and rural settings. They created a Clinical-Trial-in-a-Box tool to standardise data collection across decentralised platforms, with lessons learned applicable to Long COVID research.
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.
Home spirometry gave slightly lower percent-predicted FEV1 values than office measurements cross-sectionally, but the three-month change in lung function did not differ significantly between settings. This suggests home spirometry can reliably detect treatment effects, supporting its use as an endpoint for decentralised cystic fibrosis trials.
Rosenfeld et al., Annals of the American Thoracic Society (paywalled) · source ↗
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 ↗
The study found that acoustic speech features differed significantly between Android and iOS devices, with iOS recordings showing more periodic content but less high-frequency energy, while Android devices exhibited greater measurement variability. These platform-specific differences, coupled with participant experience challenges such as iOS users struggling with background noise checks, demonstrate that device choice and app instruction design materially affect data quality and trial outcomes in decentralised digital biomarker studies.
Chappie et al., Journal of voice : official journal of the Voice Foundation (paywalled) · source ↗
A randomised trial of 47 participants using a mobile app integrated with remote patient monitoring devices achieved a 74% biomarker submission rate over four weeks, with system usability scores of 77–94 and acceptability exceeding benchmarks, showing the platform is feasible for remote data collection in decentralised clinical trials.
Dahne et al., Journal of clinical and translational science · source ↗