FDA Commits to DHTs for Clinical Drug Development

Plan to include framework, oversight, and external input on policy governing the use of digital health technologies for modernizing clinical trials

The Food and Drug Administration (FDA) will back digital health technologies (DHTs) for advancing biological drugs and products through the Framework for the Use of DHTs in Drug and Biological Product Development program, part of the Prescription Drug User Fee Act VII.

DHTs offer many potential benefits in drug development and the advancement of medical products that use electronic sensors, computing platforms, and information technology to obtain clinical trial data directly from patients, creating new opportunities for a higher level of healthcare.

According to FDA, the framework will include "workshops and demonstration projects; engagement with stakeholders; establishment of internal processes to support the evaluation of DHTs for use in drug development; promotion of shared learning and consistency regarding DHT-based policy, procedure, and analytic tool development; and publication of guidance documents" while also convening public meetings.

The framework will also create a DHT steering committee, comprising senior staff from the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, and the Center for Devices and Radiological Health, including the Digital Health Center of Excellence, as well as the Oncology Center of Excellence and the Office of Clinical Policy and Programs.

The committee will help implement the framework and assist with activities and consistent approaches for reviewing drug submissions that contain DHT-derived data. The committee will also engage external stakeholders on DHT-related issues in human drug development and gather information about the present state of DHTs and specific challenges in their use.

Sections 3606 and 3607 of the Food and Drug Omnibus Reform Act of 2022 outline additional requirements for FDA to publish guidance regarding the modernization of clinical trials through decentralized clinical trials (DCTs) and DHTs. The agency encourages stakeholders to reach out early if they are considering using DHTs in drug development or conducting DCTs.

FDA held public webinars in February and March on using DHTs for remote data acquisition and priorities for developing DHTs to support clinical trials. FDA has said it plans to convene a series of additional public meetings or workshops to engage key stakeholders interested in using DHTs in drug and biological product development, including patients, biopharmaceutical companies, developers, and academics.