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Updated: Mar 25, 2026

Setup of Consumer Wearable Devices for Exposure and Health Monitoring in Population Studies
Published on: February 3, 2023
Wearable technologies in clinical trials for drug development: trends and emerging opportunities
Zahi A Fayad1,2,3, Robert P Hirten4, Girish N Nadkarni5,6,7
1The BioMedical Engineering and Imaging Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Abstract:
Wearable technologies are increasingly being integrated into clinical trials, offering new tools to capture physiological and behavioural endpoints in real-world settings. By enabling continuous, remote, participant-friendly monitoring, wearables address key limitations of traditional trials, such as frequent site visits, sparse sampling and limited ecological validity, while supporting the development of digital biomarkers. To characterize how wearables are used in drug development, we curated 1,021 interventional trials registered between 2001 and 2025 that incorporated wearable-derived data into study protocols. We identified five application archetypes - drug effects, dosing optimization, adherence, delivery medium and delivery technique optimization - through which wearables are deployed in trials, underscoring a broadening role across study objectives. Adhesive patches, largely driven by continuous glucose monitoring, now dominate trial deployments, with expanding coverage of physiological domains including sleep, cardiovascular function, motor activity and brain signals. Despite this progress, formal regulatory qualification of wearable-derived measures remains rare, with SV95C in Duchenne muscular dystrophy the only such example to date. Looking ahead, we highlight emerging biochemical sensing modalities beyond glucose, as well as transdermal spectroscopy and wearable ultrasound. This Review provides a structured, forward-looking overview of wearables in trials and supports their responsible, effective integration into clinical development.
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