Remote Monitoring and Data Collection for Decentralized Clinical Trials

This review suggests that decentralised clinical trials in oncology can improve patient participation and equity but face significant regulatory, logistical and digital hurdles. It concludes that these trials offer a flexible model dependent on specific clinical contexts rather than a universal replacement for conventional methods.

From site-centered to patient-centered: Promises and challenges of decentralized clinical trials in oncology — Gentile et al., Critical reviews in oncology/hematology (paywalled) · source ↗

• oncology
• dct

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

Hybrid decentralized oncology trials are feasible in community hospitals beyond traditional networks, reducing logistical and financial burdens and enabling rapid initiation and patient referrals within three months.

Building HOPE: operationalizing hybrid decentralized oncology clinical trials with community providers beyond traditional healthcare system networks — Morrison et al., The oncologist · source ↗

• dct
• oncology