Can Consumer Wearable Data Support Clinical Trial Endpoints?

Consumer wearables can enable frequent, real-world clinical-trial data collection while helping reduce participant burden. Their suitability, however, depends on the endpoint, device, firmware, and algorithm configuration, study population, and evidence that the technology is fit for its intended use. 

Originally published in Applied Clinical Trials, this expert article examines the validity, reliability, data privacy, and regulatory considerations sponsors should evaluate before incorporating consumer-grade devices into regulated clinical research. Explore Signant’s approach to electronic clinical outcome assessment and digital health technologies in clinical trials to see how endpoint, evidence, and operational design come together. 

What you’ll learn 

• How to select consumer wearables based on a clinically meaningful endpoint and fit-for-purpose validation evidence
• Why group-level accuracy can mask substantial participant-level measurement variation
• How device updates, proprietary algorithms, participant wear behavior, and data syncing can affect data consistency and integrity
• What evidence from sleep and cardiovascular studies reveals about matching devices to their intended use 
• Key FDA and EMA considerations for privacy, data security, and wearable-derived data in regulated clinical research 

Publication and authors 

Lauren Crooks, MSc, Director, Science & Medicine, Signant Health  
Greta Marie van Schoor, PhD, Associate Director, Science & Medicine, Signant Health  
Anthony Everhart, MD, Clinical Vice President, Internal Medicine, Signant Health  
Bill Byrom, PhD, Vice President, Product Intelligence & Positioning, Signant Health  
Thijs Sondag, Head of Product, WeGuide