Implementing sensor-based digital health technologies in clinical trials: Key considerations from the eCOA Consortium

Area of Science:

• Clinical Trials
• Digital Health Technologies
• Patient Compliance

Background:

• Sensor-based digital health technologies (DHTs) are increasingly used in clinical trials.
• Implementation challenges can lead to participant burden, suboptimal compliance, and hinder regulatory data use.
• Despite benefits, DHT adoption and data utilization for decision-making remain lower than anticipated.

Purpose of the Study:

• To provide holistic considerations for implementing sensor-based DHTs in clinical trials.
• To identify mechanisms for enhancing participant compliance with DHTs.
• To optimize clinical trial design and conduct through effective DHT deployment.

Main Methods:

• Gathering collective experience from the Electronic Clinical Outcome Assessment (eCOA) Consortium on DHT deployment.
• Supplementing experience with relevant literature on mechanisms to enhance participant compliance.
• Analyzing the DHT implementation process, including measure selection, data capture, sensor use, and participant burden.

Main Results:

• DHT implementation involves identifying clinical concepts, selecting digital measures, defining data capture, and considering sensor details.
• Participant and site burden must be carefully assessed and managed throughout trial stages.
• Early engagement with patient groups, physicians, and technology providers is crucial for optimizing trial design.

Conclusions:

• Holistic considerations for sensor-based DHT implementation can optimize participant compliance.
• Minimizing participant and site burden is key to successful DHT integration in clinical trials.
• Strategic planning and stakeholder engagement are essential for maximizing the benefits of DHTs in clinical research.