Claude Price, vice president and head of clinical data management at Quanticate explains the fundamental use of wearables for collecting real-world data, especially in clinical trials.
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Wearables concept
Data collection in clinical trials is poised for a transformative shift, thanks to the advancements of wearable technology. Gone are the days when clinical trials were solely dependent on intermittent visits to healthcare facilities, where data gathering was restricted to traditional methods such as physical tests and patient self-reports. This shift promises to reshape how we gather and interpret real-world data in clinical trials, allowing for continuous, remote monitoring of patients and breaking away from the constraints of traditional methodologies.
Traditional vs. wearable-driven data collection
Traditionally, clinical trials have been heavily reliant on data collected during intermittent visits to healthcare facilities. This data, obtained through a variety of tests, measurements, and patient-reported outcomes, has been the backbone of clinical research. However, it comes with limitations, including infrequent data capture and potential biases in self-reported information.
Enter wearable technology. These devices such as smartwatches, fitness trackers, and specialised medical wearables are redefining data collection by providing continuous, real-time monitoring capabilities. This approach allows for the gathering of a vast array of data points in a patient's natural environment, offering a more accurate and comprehensive picture of their health and the effects of treatments.
The impact of wearable technology in clinical trials
Continuous monitoring: The ability to monitor patients constantly is a game-changer. Wearables can track heart rate, blood pressure, sleep patterns, and physical activity continuously. This wealth of data, collected over extended periods, reveals trends and variances that periodic health visits might miss. The challenge lies in managing and analysing this data deluge, necessitating advanced data processing and robust statistical methods.
Objective data collection: Wearables significantly reduce the reliance on self-reported data, which is often subjective and prone to inaccuracies. By providing objective, quantifiable data, these devices enhance the reliability of trial results. However, ensuring the accuracy and precision of wearable devices is critical, as data integrity is paramount in clinical research.
Enhanced patient centricity: With wearables, the need for frequent site visits is greatly reduced, lowering the burden on trial participants. This approach can boost patient recruitment and retention, crucial factors in the success of a clinical trial. Wearables not only make participation more convenient but also enable a more inclusive approach by reaching a broader demographic.
Reduced data gaps: Wearables actively engage patients in the trial process. They can prompt behaviour, remind patients of necessary actions, and provide immediate feedback. This interactive aspect can lead to better adherence to treatment protocols and healthier lifestyle choices, thereby reducing the incidence of missing data, which is a significant challenge in traditional trials.
Diverse data types: Beyond standard clinical metrics, wearables can detect nuanced health indicators like gait abnormalities or tremors, particularly useful in trials involving neurological conditions. This expanded data set, captured in natural settings like a patient's home, provides a more authentic and comprehensive understanding of health outcomes.
Proactive health management: Continuous monitoring enables early detection of adverse events or significant health changes, allowing for timely interventions. This proactive approach has the potential to improve patient outcomes and prevent more severe health complications.
Challenges and validation of wearable devices in clinical trials
Despite the apparent advantages, integrating wearables into clinical trials isn't without challenges. Issues like data privacy, accuracy, participant compliance, and the need for sophisticated data analysis methodologies must be carefully addressed.
A critical aspect is the validation of wearable devices for clinical use. Just as drugs undergo rigorous trials, wearables too must be subjected to validation studies. These trials assess the device's accuracy, reliability, user-friendliness, and safety against established medical standards. For example, a wearable intended for blood pressure monitoring would need to be compared against traditional blood pressure cuffs to establish its efficacy. The design of these trials involves:
- Study design - These trials should be meticulously designed, involving comparisons against a reference standard to validate the wearable's performance.
- Accuracy and reliability - The focus is on ensuring the wearable's measurements are accurate and consistent.
- Usability and user experience - Understanding the practicality and acceptability of the device from a user's perspective is vital.
- Safety and adverse events - Monitoring for any potential risks associated with the device's use is essential.
- Data handling and integration- Ensuring compatibility with existing data management systems is crucial.
- Regulatory considerations - Compliance with regulatory bodies is mandatory for the device's approval for clinical use, with bodies like the FDA or EMA setting guidelines for the use of wearables in clinical trials.
Conclusion
Wearable technology stands as a formidable tool in enhancing the collection of real-word data in clinical trials. Its contribution to decentralized trials is increasingly recognised, as it offers a more dynamic, precise, and patient-centric approach to data collection. While wearable devices could still find utility within healthcare facilities, their true potential is most effectively realised when they are employed in the actual settings where patients live their daily lives. This out-of-clinic data collection not only complements but also surpasses the capabilities of other tools like electronic Patient-Reported Outcomes (ePRO) and electronic Clinical Outcome Assessments (eCOA), as well as patient registry data.
However, to fully harness its potential, each wearable must undergo rigorous validation and meet the stringent criteria set forth by regulatory agencies. While challenges exist, the potential benefits in terms of enhanced trial efficiency, richer data sets, and improved patient outcomes are immense. As the technology evolves and integrates more seamlessly into clinical research frameworks, wearables are poised to become indispensable tools for medical knowledge and advancement.
