P108: Wearables as Digital Endpoints: Real-World Case Studies and Regulatory Challenges in Clinical Research
Poster Presenter
Srividya Narayanan
Student
Northeastern University United States
Objectives
To systemically analyze the case studies and literature assessing the use of wearables as digital endpoints in clinical trials, emphasizing their effectiveness in capturing health metrics, clinical efficacy, regulatory obstacles, and potential for enhancing trial outcomes and patient engagement.
Method
This review analyzes data from 25 peer-reviewed articles and case studies published between 2008 and 2023. It focuses on wearable technologies applied in cardiology, neurology, and chronic disease management. The review explores the role of wearables in patient monitoring, real-time data collection,
Results
The findings indicate that wearables, such as smartwatches, fitness trackers, and heart rate monitors, facilitate continuous, real-time health data collection, providing more consistent endpoints than traditional methods. Metrics like heart rate variability, physical activity, and sleep patterns were commonly captured. In cardiology trials, wearables improved adherence by 25% on average, while in chronic disease management, they enhanced patient engagement by 30%. Despite these advantages, regulatory challenges persist, particularly regarding data validation, standardization, and privacy compliance under FDA and EMA frameworks. Addressing these challenges through robust validation protocols is essential for broader adoption.
Conclusion
Wearable devices offer transformative potential as digital endpoints in clinical trials. They can enable enhanced patient monitoring, improve data reliability, and foster participant engagement through real-time data collection. However, unresolved regulatory issues related to data integrity, standardization, and privacy must be addressed. Future research should prioritize developing standardized validation frameworks and regulatory strategies to support the seamless integration of wearables in clinical trial methodologies, ultimately reducing costs and promoting patient-centric research.
