Decentralized clinical trials in the trial innovation network: Value, strategies, and lessons learned

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.

Operational and Clinical Insights from a Fully Decentralized Clinical Study Evaluating Protocol Adherence, Participant Satisfaction, and Connected Device Data in Individuals with Type 2 Diabetes on Different Treatment Regimens — Nørgaard et al., Diabetes technology & therapeutics (paywalled) · source ↗

• dct
• actigraphy
• wearable
• multimodal
• cgm
• rpm
• interstitial-fluid

Viloxazine extended release improved ADHD, depression and anxiety symptoms in adults with comorbid conditions during a 14-week decentralised trial. The study demonstrates that remote monitoring via televisit, mobile app and home devices can deliver real-world efficacy and safety data for psychiatric medications.

Viloxazine Extended Release in Adults With Attention-Deficit/Hyperactivity Disorder and Depression and/or Anxiety Symptoms: Results From a Decentralized, Open-Label, Phase 4 Trial — Adler et al., The Journal of clinical psychiatry (paywalled) · source ↗

• dct
• rpm

A proof-of-concept decentralised trial generated 169 support tickets over 17 months from 90% of sites, with device-related problems accounting for 46% of requests. Most issues were resolved within three days and required two to six exchanges, demonstrating that robust technical support infrastructure is essential for successful remote monitoring and wearable-based trial conduct.

Toward Effective Technology Support in DCTs: Insights from the Trials@Home Proof-of-Concept Trial RADIAL — Weitlaner et al., Journal of medical systems · source ↗

• dct
• wearable
• rpm

A hybrid decentralised clinical trial using wearable dosing-monitoring and remote adverse-event reporting in healthy adults achieved 100% adherence with only 2% missing data, maintained adverse-event detection sensitivity, and was rated less burdensome than conventional on-site visits. These findings support the feasibility and reliability of participant-centric remote monitoring in early-phase pharmacokinetic studies.

Pioneering a Hybrid Decentralized Clinical Trial in South Korea: Assessing Feasibility, Data Integrity, and Participant Perceptions — Kim et al., Clinical and translational science · source ↗

• dct
• wearable
• rpm

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