Wearables in clinical trials have become an essential component of modern clinical research. These enable sponsors to collect continuous and objective data that provides deeper insights into patient health and treatment response.
From measuring mobility and sleep quality to monitoring respiratory function and cardiac activity, wearable technologies are helping researchers capture meaningful outcomes beyond the traditional clinical setting.
However, selecting the right wearable sensor is not as simple as comparing technical specifications or choosing the newest device on the market. Every clinical trial has unique scientific objectives, operational requirements, and patient populations.
There are unique regulatory considerations for each trial as well that influence which technology is most appropriate. A sensor that performs exceptionally well in one study may not be suitable for another.
For sponsors, the device selection process has important implications for data quality, endpoint development, participant experience, and ultimately the success of the clinical trial. This article explores how sponsors can evaluate wearables in clinical trials and outlines the key factors that should guide wearable sensor selection.
Understanding Wearables in Clinical Trials
Wearables in clinical trials are digital devices that continuously or periodically collect physiological or behavioral data from study participants throughout a clinical study. These allow researchers to monitor health and function remotely while reducing reliance on infrequent clinic-based assessments.
Wearable technologies include smart watches, activity monitors, biosensors, respiratory monitoring devices, cardiac sensors, and other connected health technologies. These devices may measure physical activity, gait, sleep, heart rate, respiratory patterns, temperature, or other clinically relevant outcomes.
The value of wearables in clinical trials extends beyond convenience. By collecting objective measurements in real-world environments, wearable sensors provide sponsors with a more comprehensive understanding of patient health, disease progression, and treatment response.
As decentralized and hybrid clinical trials become increasingly common, wearable technologies are also supporting more patient-centered approaches to research. These devices are also enabling richer datasets that can strengthen clinical evidence.
Why does Selecting the Right Wearable Sensor Matter?
The quality of wearable sensor data depends largely on selecting technology that aligns with the goals of the clinical trial. Even the most advanced device cannot compensate for poor alignment between the technology and the study objectives.
Choosing an inappropriate sensor can introduce unnecessary operational complexity, reduce participant adherence, and generate measurements that do not adequately support clinical or regulatory objectives.
Conversely, selecting the right wearable technology helps sponsors collect meaningful, reliable, and interpretable data throughout the study. An effective selection process supports several important goals, such as:
- Improved data quality
- Better participant experience
- Stronger digital biomarker development
- More meaningful digital endpoints
- Greater operational efficiency
- Increased confidence during regulatory interactions
Rather than beginning with available devices, sponsors should begin by understanding what they need to measure and why those measurements matter.
Start With the Clinical Question
Every wearable sensor selection process should begin with the scientific objectives of the study. Before evaluating technologies, sponsors should clearly define the clinical concept they intend to measure.
This concept should reflect outcomes that are meaningful to patients, clinicians, and regulators. Some trials measure mobility, physical function, and sleep quality. Meanwhile, respiratory performance, cardiac health, daily activity, and disease progression are other measurable outcomes.
Once the clinical concept has been established, sponsors can identify technologies capable of accurately measuring that outcome. Starting with the research question rather than the technology helps ensure that wearable sensors contribute directly to study objectives.
Evaluate Measurement Capabilities
After defining the clinical concept, sponsors should evaluate whether potential wearable sensors can accurately capture the intended measurements. Different devices use different sensing technologies, sampling rates, algorithms, and analytical methods.
Two devices may appear similar while producing substantially different data. Sponsors should evaluate whether a device can:
- Measure the intended physiological or behavioral characteristic
- Produce reliable and reproducible measurements
- Capture sufficient data throughout the study
- Support clinically meaningful interpretation
- Generate outputs suitable for digital biomarkers or digital endpoints
Selecting technology based solely on manufacturer specifications may overlook important scientific considerations. A comprehensive evaluation should focus on whether the measurements support the intended clinical application.
Consider Validation and Scientific Evidence
Validation is one of the most important considerations when selecting wearables in clinical trials. Sponsors should seek evidence demonstrating that a wearable sensor accurately measures the intended concept and performs consistently across the target population.
Several aspects of validation should be considered. Let us take a closer look at these aspects of validation and how each one is important.
Analytical Validation
Analytical validation demonstrates that the sensor performs reliably under expected conditions. Sponsors should evaluate measurement accuracy, precision, repeatability, and algorithm performance.
Clinical Validation
Clinical validation establishes that the wearable-derived measurements are clinically meaningful and associated with relevant patient outcomes. Evidence may include published studies, validation research, or previous clinical trial experience.
Context of Use
Validation should always be evaluated within the intended context of use. A wearable sensor validated for healthy adults may not perform similarly in patients with neurological disorders, respiratory disease, or mobility limitations.
Understanding these differences helps sponsors make more informed technology decisions. It also ensures that any clinical trial considers and caters to each type of validation necessary, hence building credibility.
Assess Participant Experience
Even the most scientifically robust wearable sensor may generate poor-quality data if participants are unwilling or unable to use it consistently. Participant experience should therefore remain a central consideration throughout the selection process.
Sponsors should evaluate a device for its comfort, ease of use, user interface, and battery life as the main parameters. Moreover, they must also consider any charging requirements and wear time expectations to ensure easy accessibility.
Minimizing participant burden often improves adherence, leading to more complete datasets and fewer operational challenges. Patient-centered device selection ultimately supports both data quality and study success.
Evaluate Operational Requirements
Wearable sensor selection also has important operational implications. Sponsors should assess how each technology integrates into existing clinical trial workflows and whether operational demands are realistic across study sites and participant populations.
Operational considerations include:
- Device provisioning
- Shipping and logistics
- Technical support
- Device replacement procedures
- Data synchronization
- Training requirements
- Site workflows
A technology that performs well scientifically but creates excessive operational complexity may increase study costs and implementation risks. Balancing scientific performance with operational feasibility is essential.
Consider Data Management and Analytics
Wearables in clinical trials generate large volumes of continuous data. Sponsors should evaluate how sensor data will be collected, processed, stored, monitored, and analyzed throughout the study.
Important considerations include:
- Data quality monitoring
- Missing data management
- Secure data transfer
- Integration with study databases
- Analytical workflows
- Statistical reporting
Without a robust data management strategy, even high-quality wearable technologies may fail to produce meaningful clinical insights. Planning for data management early in the selection process reduces downstream challenges.
Align Wearable Selection With Regulatory Expectations
Regulatory agencies increasingly recognize the value of wearable technologies in clinical research. However, acceptance depends on the quality of the evidence supporting the measurements rather than the technology itself.
Sponsors should consider whether the wearable sensor supports:
- Fit for purpose measurement
- Analytical validity
- Clinical validity
- Reliable data collection
- Clearly documented methodologies
Early regulatory planning helps ensure that wearable-derived measurements can support digital biomarkers, digital endpoints, and future submission activities when appropriate.
Common Mistakes to Avoid
Selecting wearables in clinical trials involves numerous decisions, and several common mistakes can reduce the value of digital measurement programs. Here are a few common mistakes associated with selection of wearables in clinical trials.
Choosing Technology Before Defining Objectives
Technology should always support the research question rather than drive it. Beginning with available devices instead of clinical objectives often leads to unnecessary data collection without meaningful outcomes.
Prioritizing Features Over Scientific Evidence
Advanced features do not necessarily improve study quality. Sponsors should prioritize validated measurement capabilities rather than selecting devices based solely on marketing claims or technical complexity.
Underestimating Participant Burden
Comfort, usability, and participant engagement significantly influence adherence. Ignoring these factors may result participant discomfort and burden. This can easily lead you to incomplete datasets and reduced study quality.
Delaying Validation Planning
Validation should begin early in the study planning process. It ensures that the study holds credibility from the start. Moreover, waiting until implementation has begun can create avoidable delays and increase regulatory uncertainty.
Recognizing these common challenges allows sponsors to make more informed decisions throughout technology selection.
Best Practices for Selecting Wearables in Clinical Trials
Organizations that successfully implement wearable technologies typically follow several best practices. Each of these is followed to ensure that the selected wearable aligns with the study requirements in the best way possible. Let us take a closer look at these practices.
Begin Planning Early
Wearable sensor selection should occur during protocol development rather than after study design has been finalized. Early planning allows technology decisions to align with endpoint strategy, statistical analysis, and operational workflows.
Collaborate Across Disciplines
Successful technology selection requires input from clinicians, statisticians, data scientists, operations teams, digital measurement specialists, and regulatory experts. Multidisciplinary collaboration helps ensure that wearable sensors support both scientific and operational objectives.
Focus on Meaningful Measurements
Sponsors should prioritize measurements that reflect clinically meaningful concepts rather than simply collecting large volumes of data. Meaningful measurements ultimately provide greater value for patients, investigators, and regulators.
Work With Experienced Digital Measurement Partners
Specialized expertise can help sponsors evaluate technologies objectively while avoiding common implementation challenges. Partners experienced in wearable sensors, digital biomarkers, digital endpoints, and validation strategies can provide valuable guidance throughout the selection process.
Collectively, these best practices help sponsors choose wearable technologies that generate reliable and clinically meaningful evidence while supporting successful study execution.
Selecting the Right Wearable Technology With VivoSense
Wearables in clinical trials continue to evolve as sensor technologies become more sophisticated. Artificial intelligence, improved sensing capabilities, remote monitoring platforms, and advanced analytics are expanding opportunities to measure patient health more accurately.
Future clinical trials are likely to incorporate increasingly personalized digital measures, broader use of digital biomarkers, and more validated digital endpoints across therapeutic areas.
Choosing the right wearable sensor is one of the most important decisions sponsors make when designing modern clinical trials. Successful sponsors must focus on selecting wearable sensors that are scientifically robust, operationally practical, and aligned with regulatory expectations.
The selected technology influences data quality and defines participant experience. It also impacts the process of digital biomarker development, digital endpoint strategy, and regulatory readiness.
VivoSense works with sponsors to evaluate wearable technologies and develop scientifically meaningful digital measures. We also validate wearable-derived outcomes and implement digital measurement strategies that support successful clinical trials.
By combining expertise in wearable sensors, digital biomarkers, digital endpoints, and regulatory science, VivoSense helps sponsors select technologies that generate reliable evidence and support confident decision-making.
Frequently Asked Questions
How do sponsors choose the best wearable sensor for a clinical trial?
The best wearable sensor is one that accurately measures the clinical concept of interest, supports participant usability, generates reliable data, and aligns with the study’s scientific and regulatory objectives.
What should sponsors evaluate before selecting a wearable device?
Sponsors should consider measurement capabilities, validation evidence, participant experience, operational requirements, data management, and regulatory expectations before selecting a wearable technology.
Are all wearable sensors suitable for clinical research?
No. Many consumer wearable devices are designed for general wellness rather than clinical research. Sponsors should evaluate whether a device has appropriate validation evidence and can support the intended context of use.
Why is participant experience important when selecting wearable sensors?
Participant comfort and ease of use influence adherence throughout the study. Better adherence leads to more complete datasets and improves the overall quality of clinical trial evidence.
Should wearable sensor selection begin before protocol development?
Ideally, yes. Selecting wearable technologies during protocol development allows sponsors to align endpoint strategy, validation activities, statistical planning, and operational workflows from the beginning of the study.