Wearable DHT 101 For Clinical Research: Foundations, Regulations, And Real-World Applications

Digital health technologies (DHTs), particularly wearable devices, are revolutionizing clinical trials by enabling continuous, remote data collection. This transformation, however, requires a well-defined regulatory strategy to ensure the validity and acceptance of DHT-derived endpoints. Regulatory bodies, including the FDA, emphasize the need for clear validation frameworks, encompassing usability, technical verification, and analytical validation to establish the reliability of digital measures.

A successful endpoint strategy for DHTs necessitates a patient-centered approach, ensuring that digital biomarkers and clinical outcome assessments (COAs) align with meaningful health outcomes. Sponsors must engage early with regulators, leveraging established guidance to integrate DHTs effectively into trial designs. Ensuring data quality, managing device interoperability, and maintaining algorithm consistency throughout the study are key deployment considerations. By addressing these regulatory and endpoint strategy challenges, DHTs can drive more precise, real-world efficacy assessments, ultimately accelerating drug development and improving patient outcomes in clinical research.