Home Spirometry as a Clinical Trial Endpoint in People with Cystic Fibrosis: Results of the OUTREACH Study

Remote motor assessment achieved a 95 percent completion rate and high caregiver acceptability in children with Canavan disease. Good to excellent inter- and intra-rater reliability demonstrates that rigorous remote assessment protocols can be implemented in decentralised trials for rare pediatric conditions, reducing burden on families.

Feasibility, Acceptability, and Reliability of Remote Motor Assessment in Children With Canavan Disease — Kiefer et al., Pediatric neurology (paywalled) · source ↗

• pediatric
• dct
• rpm
• digital-biomarker

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

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

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

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.

Evaluation of a remote biomarker capture system integrated with REDCap: A decentralized randomized trial — Dahne et al., Journal of clinical and translational science · source ↗

• dct
• acceptability
• rpm
• digital-biomarker