Mitigating fraud in a fully decentralized clinical trial of a digital health intervention

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.

Direct-to-Participant Enrollment in a Virtual Trial: Lessons Learned From the Heartline Study — Hills et al., JACC. Advances · source ↗

• dct
• wearable
• rpm
• digital-biomarker

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.

Home Spirometry as a Clinical Trial Endpoint in People with Cystic Fibrosis: Results of the OUTREACH Study — Rosenfeld et al., Annals of the American Thoracic Society (paywalled) · source ↗

• dct
• rpm
• pediatric
• digital-biomarker

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.

Artificial Intelligence in Neuromuscular Diseases: Opportunities for a Data-Scarce Field — Ma et al., Neurology and therapy (paywalled) · source ↗

• dct
• wearable
• rpm
• digital-biomarker
• validation
• biomarkers
• multi-omics

A critical assessment of recent decentralised trial experience, weighing what the model has delivered against what was claimed for it.

Decentralized Clinical Trials in the Era of Real-World Evidence: A Critical Assessment of Recent Experiences — Wang et al., Clinical and Translational Science · source ↗

• dct
• standards
• digital-biomarker

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.

Comparing Phoneme Speech Recordings and Acoustic App Data Capture Experience for Android and iOS Mobile Device Users in the Large Decentralized AcRIS Study — Chappie et al., Journal of voice : official journal of the Voice Foundation (paywalled) · source ↗

• dct
• rpm
• digital-biomarker