Wearable technologies have become a driving force in modern healthcare, transforming how data is collected, monitored, and analysed in clinical research. As patient-centric models gain traction, the integration of wearables in clinical trials—alongside sensors, digital biomarkers, and robust data management—has emerged as a key driver of innovation. By providing continuous, real-time insights, these tools empower researchers to make informed decisions faster while also enhancing participant engagement and overall trail outcomes.
What Are Wearables in Clinical Trials?
Wearables in clinical trials are electronic devices worn on or near the body that continuously or periodically collect health-related data such as heart rate, activity levels, and physiological signals. By reducing the need for frequent site visits, wearables and sensors in clinical trials allow real-time data collection that reveals nuanced insights into patient behaviours and vitals. This remote monitoring helps alleviate participant burden and often results in higher adherence rates. As such, as the industry evolves, sensors, wearables, and digital biomarkers in clinical trials are widening the scope of measurable endpoints, enabling deeper analyses of patient health.
What Are The 4 Wearable Technologies?
- Smartwatches – provide heart rate monitoring, sleep tracking, ECG capabilities, and user-friendly interfaces that improve study engagement.
- Fitness Bands/Trackers – focus on steps, calorie counts, and sleep metrics, offering cost-effective options for large patient cohorts.
- Biosensor Patches – continuously collect data on vitals like glucose or cardiac rhythms, sending results directly to cloud platforms for real-time analysis.
- Implantable or Ingestible Sensors – though still emerging, these offer detailed internal measurements over extended periods, which are vital for specialised trials requiring advanced monitoring.
The Role of Wearables in Clinical Trials
Wearables serve three critical roles in clinical data management:
Real-Time Data Collection
The continuous monitoring of metrics such as sleeping patterns, cardiac readings, and glucose levels provides immediate data for analysis. The use of wearables also enables us to capture data over a prolonged period of time without having to see the patient, which can help us understand trends and patterns in patient health and behaviour, which will ultimately benefit the clinical trial and patient.
Patient-Centric Approach
It is essential that we not only keep the patients’ needs in clinical trial at the forefront of technology but continue to innovate and normalise the requirement to advance patient centricity in clinical trials, and a key part to this is the use of wearable technologies. By minimising clinic visits and making remote monitoring the norm, wearables foster an environment where patients feel more invested in their care. This not only reduces dropout rates but also supports the rise of virtual or decentralised clinical trials, improving access for diverse populations.
Streamlined Data Integration
Seamless integration of wearable data into existing EDC systems and data workbenches simplifies real-time analysis, letting researchers adapt study designs quickly. Current industry discussions around standardisation, including those highlighted on ICH E6 (R3), emphasise utilising data strategies for more efficient and adaptive trial processes.
Additionally, wearables in clinical trials can be broken down by their broader impact which includes data collection, participant engagement, decentralised trials, and regulatory perspective.
The Impact of Wearables in Clinical Trials
Accuracy and Reliability
Many modern wearables (e.g. continuous glucose monitors) must comply with regulatory standards such as the FDA (US) or CE Mark (EU) to offer high accuracy. Proper validation processes are essential to maintaining data integrity.
Improved Data Volume and Quality
By capturing continuous streams of objective information, wearables minimise patient recall bias and generate large datasets, providing comprehensive insights into patient outcomes, adherence, and behaviours.
Enhanced Efficiency in Clinical Trials
Reduces manual data entry and errors while supporting remote and decentralised clinical trials, improving access to diverse patient populations and faster enrolment.
Predictive Insights with AI/ML
The integration of wearable data with artificial intelligence allows advanced analytics for pattern recognition and risk prediction. Early warnings about potential adverse events as a result of incorporating automation in clinical data management help tailor interventions and potentially improve patient outcomes.
In parallel with these advantages, previously noted benefits such as real-time insights, cost-effectiveness, and scalability all converge to create a more robust and responsive clinical research environment.
Pros and Cons of Wearable Devices in Clinical Trials
Opportunities and Benefits
Increased Patient Engagement and Retention
By enabling participants to actively monitor their own health metrics, wearables foster a sense of ownership that can reduce dropout rates. Real-time feedback and user-friendly apps make participants more aware of their progress, supporting a stronger connection to the study.
Continuous and Objective Data Stream
Unlike traditional self-report methods, passive data collection through wearables captures day-to-day fluctuations and long-term trends without relying on patient recall. This yields a more accurate, holistic picture of health across diverse environments.
Personalised Interventions and Treatments
Real-time monitoring allows sponsors and clinicians to quickly identify anomalies or negative trends, prompting swift modifications to therapy or study protocols. This proactive approach can help enhance patient outcomes and potentially shorten trial timelines.
Reduced Administrative Burden
Automation streamlines data capture and transfer, minimising manual input errors and freeing research teams to focus on higher-level tasks. With wearable-collected data flowing directly into study databases, overall trial management becomes more efficient.
Challenges and Considerations
Data Integrity and Validation
Due to wearable data having large amounts of data which can vary in accuracy due to the quality of device, calibration and even the behaviour of the user, it is essential that proper and correct data validation processes are put in place to ensure traceability and reliability.
Data Privacy and Security
Wearables collect sensitive health data, requiring robust data security protocols and compliance with regulations like GDPR (EU/UK) and HIPAA (US). Such measures are vital for protecting patient data.
Patient Compliance
The device The device adoption relies on consistent use; therefore, training and specifications must be made clear to all patients to enable the best use possible and limit/remove the potential for non-compliance, leading to incomplete or unreliable data. Poor adherence can compromise dataset completeness and validity for study analysis.
Data Overload
Managing large volumes of data can be challenging, necessitating data filtering and meaningful analysis to avoid "noise." Therefore, coming up with clear data handling guidelines and validation steps is critical in ensuring the management and use of wearable data.
Regulatory Uncertainties
Many ongoing efforts to standardise wearable devices and data collection continue to underscore the need for harmonised frameworks.
Real World Applications: How Are Wearables Used in Healthcare?
There are several real-world applications where not only are wearables being utilised but are becoming standard practice and the go to option for data capturing and analysis. The use of these could help path the way for wearables becoming more readily used and help drive away the stigma of using new technology. These therapeutic areas include:
- Cardiology – continuous ECG monitoring via wearables for arrhythmia detection.
- Diabetes Management – blood glucose monitors tracking glucose fluctuations.
- Sleep Disorders – wearables providing sleep stage analysis and patterns.
- Oncology – monitoring fatigue, activity levels, and other biomarkers in cancer patients.
- Chronic Disease Management and Rehabilitation – providing actionable data to clinicians and therapists, facilitating tailored treatment adjustments.
- Population Health Initiatives – aggregated wearable data informs public health policy and resource allocation.
Guidelines for Wearables in Clinical Trials
To ensure the safe and efficient integration of wearable technologies in clinical trials, sponsors and researchers must keep the following key compliance areas in mind.
Regulatory Compliance
United Kingdom (UK)
The Medicines and Healthcare Products Regulatory Agency (MHRA) oversees medical devices used in clinical trials, ensuring they meet safety and performance standards. Additionally, the National Institute for Health and Care Excellence (NICE) offers guidance on implementing effective digital health tools, including wearables and sensors.
United States (US)
The FDA has released guidance on digital health technologies, emphasising the importance of validated devices and standardised data collection methods. Clinical trial sponsors operating in the US must ensure they meet these requirements to maintain rigorous data integrity.
Data Privacy and Security
United Kingdom (UK)
Organisations must comply with the UK General Data Protection Regulation (UK GDPR) and the Data Protection Act 2018. These regulations mandate responsible data processing, robust security measures, and explicit patient consent, ensuring that participants’ rights over their personal health information are respected.
United States (US)
Federal laws such as HIPAA, along with various state regulations, govern how wearable data is collected, stored, and shared. The applicability of HIPAA depends on whether the entity handling patient data is deemed a coverage entity (e.g. healthcare providers, insurers, or their business associates).
Does HIPAA Apply to Wearable Devices?
In most cases, HIPAA protects health information maintained by covered entities. If a wearable device is part of a clinical trial sponsored by a covered entity, HIPAA obligations likely apply. However, consumer-oriented devices managed by non-covered entities may fall outside HIPAA’s scope.
Future Outlook and Trends
As wearable technology continues to evolve and permeate clinical research, several key developments are shaping the next wave of innovation.
Advancements in Sensor Technology
Ongoing research aims to broaden the range of biomarkers captured by wearables, moving beyond heart rate and glucose monitoring to include markers like sweat composition, respiration, and even neurophysiological signals. These evolving capabilities will reduce the need for invasive tests and offer richer, more granular data to inform clinical decisions.
Virtual and Decentralised Trials
As remote data collection becomes the norm, there is a growing move toward fully virtual trials, in which participants rarely—or never—visit a physical site. This shift not only increases patient accessibility but also accelerates recruitment and engagement across broader geographics regions. By minimising logistical burdens, decentralisation can drive down costs and open new opportunities for innovative trial designs.
AI and Machine Learning
Predictive analytics are set to become increasingly sophisticated, enabling clinicians and study teams to identify emerging health risks before they escalate. Through algorithms capable of analysing vast volumes of wearable data, machine learning models can recognise subtle patterns—such as early indicators of cardiovascular events—allowing for timely interventions and proactive patient management.
Integration with EHRs
Standardising data formats will be crucial for connecting wearable data with electronic health records. Achieving seamless interoperability can streamline care coordination, reduce duplicative testing, and improve patient safety. In the coming years, an increasing emphasis on unified data ecosystems will pave the way for deeper insights and a more holistic view of patient health.
Conclusion
By delivering real-time, objective data and supporting remote engagement, wearables are transforming clinical data management. Wearables in clinical trials can drive enhanced accuracy, reduce administrative burdens, and open the door to more inclusive and efficient research models. Cooperation between regulatory bodies, technology innovators, and clinical researchers is crucial to fully realise this potential. Ensuring robust validation, data privacy, and patient compliance strategies will help the industry harness the true impact of wearable technologies.
As digital tools shape the trajectory of healthcare, utilising wearables in decentralised clinical trials, alongside sensors and digital biomarkers, can revolutionise study design, patient engagement, and data-driven decision-making. This progress calls for a balanced approach to innovation, collaboration, and regulatory foresight—paving the way for patient-centred trials that deliver meaningful, real-world results.
Quanticate’s Clinical Data Management team specialise in integrating wearable technologies into clinical trials, ensuring accurate, regulatory-compliant data collection and analysis. Our tailored solutions streamline data management, enhance patient engagement, and support decentralised trials for more efficient research outcomes. If you're looking for a trusted partner to optimise your study with wearable-driven insights, submit an RFI today and discover how we can support your clinical research needs.
