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Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
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Related Experiment Video

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Setup of Consumer Wearable Devices for Exposure and Health Monitoring in Population Studies
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Implementation Framework to Increase Patient Adherence in Clinical Trials Utilizing Wearable Devices.

Meghan Lael McCarthy1, Aubrey Pope1, Gabriel Smock1

  • 1Department of Surgery, Massachusetts General Hospital, Boston MA, USA.

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|December 3, 2025
PubMed
Summary

Improving adherence in clinical trials using wearable devices requires addressing technological barriers and participant engagement. Strategies include clear criteria, digital literacy support, and regular monitoring to ensure high-quality data and equitable participation.

Keywords:
adherenceclinical trialsdigital healthdigital literacyimplementation strategiesremote monitoringwearable devices

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Area of Science:

  • Digital Health Technologies
  • Clinical Trial Design
  • Wearable Biosensors

Background:

  • Wearable devices are crucial for collecting continuous physiologic data in clinical trials.
  • Challenges like digital literacy, device syncing, and socioeconomic disparities hinder consistent patient adherence.
  • Improving adherence is essential for high-quality, analyzable data in research settings.

Purpose of the Study:

  • To synthesize insights from a clinical trial using wearable devices.
  • To develop a practical framework for optimizing adherence in wearable-based clinical trials.
  • To address challenges in collecting continuous physiologic data.

Main Methods:

  • Synthesized insights from the NIH-NHLBI-funded Wearables Clinical Trial.
  • Conducted a focused literature review on wearable device adherence.
  • Developed a framework of strategies based on practical implementation and research findings.

Main Results:

  • Key strategies include clear inclusion/exclusion criteria and flexible recruitment options (virtual/in-person).
  • Reinforcing digital literacy, regular data monitoring, and consistent participant contact are vital.
  • These approaches enhance engagement, reduce data missingness, and promote equitable participation.

Conclusions:

  • Strategies addressing technological barriers, participant engagement, and data monitoring improve adherence in wearable clinical trials.
  • The proposed framework guides optimized study design, data quality, and accessibility for diverse populations.
  • Lessons learned can inform future studies and promote digital health technology adoption in clinical research.