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

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Implementing sensor-based digital health technologies (DHTs) in clinical trials requires careful planning to minimize participant burden and enhance compliance. Addressing these factors optimizes trial conduct and data utilization for regulatory decisions.

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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.