Why Are Wearables and Sensors Still Underused in Clinical Trials?
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Sensor-based digital health technologies offer objectively assessed financial and operational benefits in clinical trials, yet adoption remains slower than anticipated. Participant burden, missing data, and unresolved questions about compliance are the primary barriers.
This open-access review, published in Clinical and Translational Science by the Critical Path Institute's eCOA Consortium, including co-author Bill Byrom of Signant Health alongside researchers from AstraZeneca, Parexel, ActiGraph, Medable, and five other organizations, provides the most complete publicly available framework for sensor-based digital health technology implementation designed to optimize participant compliance.
Key Points
- A systematic review of sensor-based digital health technology compliance found tremendous variability in both defining and reporting compliance across studies, with no established commonly accepted thresholds, though rates of 75% to 80% are generally perceived as satisfactory and rates above 90% as high.
- Compliance in one fitness tracker study decreased from 94% initially to 85% over 30 days in older adults post cardiac surgery, while a separate breast cancer study reported overall compliance of 52.5% over six months, with longitudinal rates declining to 17.5% at day 180, demonstrating the time-dependency of compliance in long-duration studies.
- Making sensor-based digital health technology use optional in a study protocol consistently leads to lower participant willingness, lower perceived data value, and insufficient data to answer research questions, a pattern that applies to any study component made optional.
- Roundtable discussions bringing together patients, clinicians, and technology providers before protocol development are more likely to produce compliant deployment designs than conversations held separately, yet open multi-stakeholder consultations remain the exception rather than the norm.
- Sharing digital health technology data with participants during a study risks introducing biofeedback and bias that could compromise evaluation of the investigational product. Current best practice places data sharing after study completion.
- The paper, published open access in Clinical and Translational Science (doi: 10.1111/cts.70054), contains the complete implementation framework across five domains, compliance data tables, and the regulatory and diversity considerations that this page does not reproduce in full.
The FDA's guidance on digital health technologies for remote data acquisition in clinical investigations, alongside EMA qualification guidance for digital technology-based methodologies, has established a regulatory framework within which sponsors are expected to demonstrate compliance adequacy. Despite that framework and despite accelerated adoption during the COVID-19 pandemic, sensor-based digital health technology uptake in interventional trials with regulatory intent has remained below expectations.
The eCOA Consortium review, published in November 2024 in Clinical and Translational Science, directly addresses the gap between the recognized potential of these technologies and their actual deployment rate. For sponsors designing trials that include sensor-based endpoints in 2025 and beyond, the considerations it sets out are the current best available evidence base for implementation planning.
The first domain covers sensor and digital measure selection, including the choice between point-in-time active tasks and continuous passive monitoring, the tradeoffs of deploying multiple sensors at different body locations, duration, and frequency of data collection relative to the minimum valid data set required, and the recommendation that mandatory rather than optional consent be obtained for digital health technology data collection.
The second covers participant data sharing and its risks to data integrity. The third addresses diversity, equity, and inclusion considerations specific to digital health technology deployment, including analytical validation requirements for racially diverse populations and evidence from COVID-19 pandemic research showing that pulse oximetry overestimated oxygen saturation in Asian, Black, and Hispanic patients compared to White patients.
The fourth covers patient, clinician, and technology provider input, with a specific argument for multi-stakeholder roundtables before protocol finalization. The fifth addresses compliance modelling using publicly available natural history datasets to anticipate data missingness and inform study power calculations before deployment.
Bill Byrom of Signant Health contributed to this review alongside first author Elena Izmailova of Koneksa Health and co-authors from AstraZeneca, uMotif, Clario, Parexel, ActiGraph, Medable, and the Critical Path Institute. The breadth of contributing organisations reflects the precompetitive nature of the framework and strengthens its applicability across sponsor, CRO, and technology provider contexts. The full paper is available open access at the link below.
"DHT deployment practices in clinical trials continue to evolve and are sometimes still perceived as a complicating aspect of study conduct due to uncertainty with predicting participant and site burden and, consequently, participant compliance in generating the data." - Izmailova et al., eCOA Consortium; Clinical and Translational Science, 2024 (doi: 10.1111/cts.70054)
What compliance rates should sponsors expect from wearable sensors in clinical trials?
There are no established, commonly accepted thresholds for sensor-based digital health technology compliance. Published research suggests 75% to 80% compliance is generally perceived as satisfactory and rates above 90% as high, but compliance is highly context dependent. Longitudinal studies consistently show compliance decreasing over time, with one breast cancer fitness tracker study reporting a decline from an initial rate to 17.5% at day 180 of a six-month follow-up.
Should digital health technology use in clinical trials be optional or mandatory for participants?
How does sensor placement affect compliance and data quality in clinical trials?
Sensor placement directly affects both participant compliance and measurement accuracy, and the optimal balance between the two varies by concept of interest. Wrist placement consistently produces higher wear compliance than hip or waist placement, particularly in adolescent populations, but waist placement may provide more accurate energy expenditure estimation for walking. Body location standards should be driven by the specific digital measure being collected, with participant preference and usability testing informing the final choice before study initiation.
AUTHOR BIO
Name: Bill Byrom
Title and Credentials: PhD, Vice President of Product Intelligence and Positioning at Signant Health
Bio: Bill Byrom, PhD, is Vice President of Product Intelligence and Positioning at Signant Health, specializing in ePRO methodology, clinical outcome assessment strategy, and digital health technology implementation in clinical trials.
The full author list spans Koneksa Health, AstraZeneca, Medable, uMotif, APDM Wearable Technologies (a Clario company), Parexel International, ActiGraph, Signant Health, and the Critical Path Institute.
Designing a clinical trial that includes sensor-based digital health technology endpoints? Speak to Bill Byrom, PhD, about compliance planning, digital measure selection, and participant burden strategy for wearable and remote data collection programs.
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