Leveraging Consumer-Grade Wearables in Clinical Trials: Insights From Digital Primary Endpoints
Author(s)
Manuel C. Cossio, BS, BSc, MS, MSc;
Cytel Inc., Digital Health, London, United Kingdom
Cytel Inc., Digital Health, London, United Kingdom
Presentation Documents
OBJECTIVES: This study evaluates the application of smartwatches, particularly the Apple Watch, in clinical trials for collecting digital primary endpoints, focusing on their potential to streamline trial processes across therapeutic areas.
METHODS: A dataset of 87 studies was extracted from ClinicalTrials.gov, limited to trials with completed or terminated status. Key characteristics such as therapeutic focus, endpoint types, geographic distribution, and study design were analyzed.
RESULTS: Of the 87 studies, 81 (93.1%) were completed, and 6 (6.9%) were terminated, with cardiology dominating (25 studies, 28.7%), followed by neurology (19, 21.8%) and oncology (10, 11.5%). Primary endpoints included ECG alterations (18.4%), heart rate variability (12%), and oxygen saturation (10%). Emerging therapeutic areas, such as mental health and oncology, utilized endpoints like mood registration (5.7%) and sleep patterns (3.4%). Interventional studies (64%) were more prevalent than observational ones, with recruitment rates exceeding 80% in most cases. Geographic analysis showed trials were primarily conducted in North America (55%), followed by Europe (30%). Validation studies confirmed the high diagnostic accuracy of wearable devices for regulatory submission.
CONCLUSIONS: The increasing adoption of wearables in clinical trials highlights their potential to enhance patient engagement, reduce costs, and improve scalability. However, challenges such as technical reliability and adherence must be addressed. Further research should explore their integration into value-based healthcare and global trial frameworks.
METHODS: A dataset of 87 studies was extracted from ClinicalTrials.gov, limited to trials with completed or terminated status. Key characteristics such as therapeutic focus, endpoint types, geographic distribution, and study design were analyzed.
RESULTS: Of the 87 studies, 81 (93.1%) were completed, and 6 (6.9%) were terminated, with cardiology dominating (25 studies, 28.7%), followed by neurology (19, 21.8%) and oncology (10, 11.5%). Primary endpoints included ECG alterations (18.4%), heart rate variability (12%), and oxygen saturation (10%). Emerging therapeutic areas, such as mental health and oncology, utilized endpoints like mood registration (5.7%) and sleep patterns (3.4%). Interventional studies (64%) were more prevalent than observational ones, with recruitment rates exceeding 80% in most cases. Geographic analysis showed trials were primarily conducted in North America (55%), followed by Europe (30%). Validation studies confirmed the high diagnostic accuracy of wearable devices for regulatory submission.
CONCLUSIONS: The increasing adoption of wearables in clinical trials highlights their potential to enhance patient engagement, reduce costs, and improve scalability. However, challenges such as technical reliability and adherence must be addressed. Further research should explore their integration into value-based healthcare and global trial frameworks.
Conference/Value in Health Info
2025-05, ISPOR 2025, Montréal, Quebec, CA
Value in Health, Volume 28, Issue S1
Code
RWD89
Topic
Real World Data & Information Systems
Disease
SDC: Cardiovascular Disorders (including MI, Stroke, Circulatory), SDC: Diabetes/Endocrine/Metabolic Disorders (including obesity), SDC: Mental Health (including addition)