Analysis Method of Real-World Digital Biomarkers for Clinical Impact in Cancer Patients
Oakley-Girvan et al.
The finding, in our words
In 50 cancer patients monitored at home with an Apple Watch for 28 days, a method that classified missing step data by gap duration and context produced the most reliable daily step estimates. Daily step counts on days with at least ten hours of wear time predicted time to first clinical event (p=0.068) and identified participants at lower hazard of mortality, with 83.3% accuracy for clinical event prediction, demonstrating that processed consumer wearable data can support remote monitoring in decentralised oncology trials.
A paraphrase to the Library’s standard, never the abstract. The source is one link away and is always the authority.
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 ↗
Decentralised monitoring of people with type 2 diabetes using continuous glucose monitoring and a hybrid smartwatch was feasible, with high participant retention and successful collection of glucose, heart rate, activity, sleep and GPS data via a study app.
Ali et al., Journal of diabetes science and technology (paywalled) · source ↗
A fully remote decentralised clinical trial in Danish adults with type 2 diabetes demonstrated operational feasibility with rapid recruitment, high retention (87 percent), and excellent adherence to continuous glucose monitoring (95 percent achieving ≥70 percent data coverage) and telemedicine visits (97 percent). Activity tracker adherence was poor (12 percent) due to technical issues, but remote safety monitoring was effective with no unexpected adverse events, supporting the viability of remote diabetes management.
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.