FDA Advancing Technological Innovations in Clinical Investigations

Technological advances provide opportunities to facilitate efficient clinical investigations. The U.S. Food and Drug Administration intends to provide the clarity needed to encourage the exploration of these technological advances. As a part of FDA’s efforts to be responsive to this rapidly evolving technological ecosystem, today, the agency issued a draft guidance titled Digital Health Technologies for Remote Data Acquisition in Clinical Investigations Guidance for Industry, Investigators, and Other Stakeholders. The draft guidance provides recommendations to sponsors, investigators, and other stakeholders on the use of digital health technologies (DHTs) to acquire data remotely from participants in clinical investigations evaluating medical products.

DHTs can remotely record and analyze data directly from clinical investigation participants while participants are sleeping or performing daily tasks. They can also help to provide a broader picture of how participants function at home, school, work, or outdoors. DHTs may also facilitate the direct collection of information from participants who are unable to report their experiences such as infants or cognitively impaired individuals. DHTs may also facilitate innovative clinical trials designs, such as trials with pragmatic elements.

This draft guidance provides recommendations to facilitate the use of DHTs in clinical investigations. It is designed to help accelerate efficient medical product development to help bring new innovations and advances to patients. This effort is an FDA cross-center collaboration including the Center for Drug Evaluation and Research (CDER), the Center for Biologics Evaluation and Research (CBER), the Center for Devices and Radiological Health (CDRH), and the Oncology Center of Excellence. This collaborative effort builds on the launch of the Digital Health Center of Excellence to empower digital health stakeholders and provide regulatory clarity.

For information on the draft guidance and how to comment, please see the Federal Register Notice. FDA will conduct a webinar on the draft guidance. Visit the CDER Small Business & Industry Assistance webpage for upcoming information on webinar registration.