Wearable Devices in Clinical Trials: Technologies for Continuous Patient Monitoring

Abstract

Wearable devices are transforming clinical research by enabling continuous, remote, and real-world monitoring of physiological and behavioural parameters. Conventional clinical trials frequently rely on intermittent assessments obtained during scheduled site visits, which may provide only a limited representation of a participant’s health status. Wearable technologies-including smartwatches, smart rings, sensor-embedded patches, continuous glucose monitoring systems, electrocardiographic patches, and activity monitors can generate high frequency longitudinal data in participants’ everyday environments. These data can be processed into digital measures and, when appropriately validated, digital biomarkers or digital clinical outcome assessments. Recent evidence indicates rapid growth in usage of wearable- derived measurements into interventional clinical trials. A 2026 analysis identified 1,021 interventional trials registered between 2001 and 2025 that incorporated wearable- derived data, demonstrating the increasing role of wearables in drug development. Wearables can support assessment of physical activity, mobility, gait, sleep, heart rate, cardiac rhythm, glucose, respiratory parameters, temperature, medication adherence and treatment-related changes. Their incorporation may reduce dependence on site-based assessments, improve ecological validity, and enable more frequent measurement of treatment effects. However, technological variability, sensor accuracy, missing data, participants’ burden, interoperability, cyber security, privacy, algorithmic bias, and insufficient clinical validation remain important barriers. Regulatory agencies have consequently emphasized fit-for-purpose technology selection, analytical and clinical data validation, data integrity, and patient protection. This review discusses the technologies underlying wearable monitoring, their applications in clinical trial, the development of digital end points, considerations, limitations, and prospective directions. The integration validated wearable-derived measures with conventional clinical endpoints has the potential to create more continuous, patient-centred, and decentralised approaches towards clinical research.