Different Stakeholder Perspectives On Navigating The FDA's DHT Guidance

Digital health technologies (DHTs) offer innovative ways to capture multidimensional patient data remotely and passively, which holds promise for enhancing clinical trials. However, the integration of DHTs in drug development has been limited by regulatory uncertainties. The FDA’s recent guidance, "Digital Health Technologies for Remote Data Acquisition in Clinical Investigations," provides much-needed clarity for sponsors and developers on implementing DHTs, promoting safer and more effective data capture. This framework supports decentralized trials, enabling comprehensive, real-time health monitoring and facilitating patient-centered endpoints that capture meaningful aspects of quality of life.

DHTs provide unique opportunities for accurate, real-world data capture, improving patient recruitment and retention. In a recent panel, industry leaders discussed the guidance’s implications, such as establishing "fit-for-purpose" DHT validation and aligning on standardized endpoints. These insights underscore the importance of leveraging high-quality data from DHTs while focusing on developing valid clinical measures rather than specific devices.