2025 · Clinical and Translational Science · open access
Wang et al.
A critical assessment of recent decentralised trial experience, weighing what the model has delivered against what was claimed for it.
A paraphrase to the Library’s standard, never the abstract. The source is one link away and is always the authority.
2026
The study identified 48 strengths, 62 weaknesses, 5 opportunities, and 13 threats across eight key trial activities in decentralised clinical trials, highlighting potential advantages like remote participation and challenges such as digital technology barriers and privacy issues.
SWOT analysis of decentralised clinical trials from an ethical, legal, regulatory and operational perspective — Murciano-Gamborino et al., BMC medical ethics · source ↗
2026
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 ↗
2026
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 ↗
2026
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 ↗
2025
A recommendation paper on extending decentralised elements in trials, covering the conditions under which trial activity, including biological sample collection, may take place away from the investigator site.
Recommendation Paper on Advancing the Use of Decentralised Elements in Clinical Trials — Bond et al., Therapeutic Innovation & Regulatory Science · source ↗