Consumer wearables are moving into clinical research faster than most wellness brands have noticed: the global decentralized clinical trial market sat at $8.8 billion in 2024 and is on track to reach $18.8 billion by 2030, according to BCC Research, and wearable-generated endpoints are a large part of what is pulling that spending out of traditional site-based settings. For supplement, skincare, and pet health companies running their own product validation studies, that shift has a practical consequence: continuous passive data collection from devices participants already own can replace scheduled lab visits, which cuts logistics costs and removes the geographic ceiling on enrollment.
The appeal is real, but so is the accuracy gap that researchers need to account for before building a primary endpoint around a consumer device. A peer-reviewed comparison of the Oura Ring Gen3, Fitbit Sense 2, and Apple Watch Series 8 against polysomnography in 35 participants found all three detected sleep versus wake with sensitivity above 95 percent. Distinguishing sleep stages was a different story: accuracy dropped across all devices, and the degree varied by device and stage. That distinction matters when a brand wants to claim a supplement improves REM sleep specifically, since a single consumer wearable is unlikely to survive scrutiny as the sole source of evidence for that claim.
The FDA’s 2023 guidance on digital health technologies for remote data acquisition sets out what the agency expects when wearable data enters a clinical investigation: device selection needs to match the measurement, and validation against reference standards has to happen before the device is used to assess the product being studied. Heart rate and daily step counts clear that bar comfortably on most commercially available devices. Stress quantified solely through heart rate variability on a consumer smartwatch is harder to defend without supporting validation data, because the literature treating HRV as a stress biomarker is still unsettled enough that regulators and the FTC both want the methodology disclosed, not just the result.
Brands that get this right treat device selection as a design decision, not a technology choice, picking the metric first, then confirming the device measures it reliably enough to support the specific claim they intend to make. Those that skip that step tend to generate data their marketing team cannot actually use. The metric to watch as this approach matures is whether wearable-derived endpoints start appearing in FDA submissions for over-the-counter health claims, which would force the agency to state explicitly how it weighs consumer-device accuracy against study-grade measurement.
Source link: https://www.citruslabs.com/post/wearables-in-clinical-trials
Moe Alsumidaie, MBA, MSF, is founder and Chief Editor of Vanguard Publications, which publishes Clinical Trial Vanguard, Pharma Vanguard and BullScope, and Head of Research at CliniBiz. He has two decades in clinical trial operations and data science, with earlier roles at Genentech, Abbott Vascular and Stanford University Medical Center, and is a guest lecturer in clinical trial sciences at Rutgers University.
