FDA Outlines Next Steps to Weave Digital Health Data Into Clinical Trials

The FDA Thursday delineated how it intends to build the knowledge necessary to consider information collected from digital health technology (DHT) used in the development of new drugs and biologics, which has the promise of opening clinical research to a wider pool of individuals who could participate in trials that are essentially conducted in real-world settings.

The framework document was required by the 2023-2027 Prescription Drug User Fee Act VII commitment letter, which includes the goal of building DHT infrastructure into drug development.

The document adds more detail to the thought process the FDA will use as it creates its regulatory decision-making capabilities in considering DHT-derived data and follows the December 2021 release of a guidance document, called Digital Health Technologies for Remote Data Acquisition in Clinical Investigations.

DHT incorporates wearable, implantable, ingestible, and environmental sensors and software applications, enabling remote capture of clinical information.

The FDA said it plans to hold the first of a series of 5 public meetings or workshops with DHT firms, biopharmaceutical companies, patients, and researchers by the end of the second quarter of fiscal year 2023. It also anticipates releasing another 2 draft guidance documents, Decentralized Clinical Trials for Drugs, Biological Products, and Devices, followed by Regulatory Considerations for Prescription Drug Use-Related Software.

Besides the workshops, the FDA will also conduct up to 3 demonstration projects and create internal processes to support DHT evaluation for use in drug development, among other things.

“By reducing the burden on trial participants, DHTs may increase trial recruitment rates, help retain participation over longer periods of time, and increase participant diversity," the FDA noted.

In addition, the use of DHTs may allow participation from people who can't communicate, such as infants or those who are cognitively impaired.

This advance will allow for a “broader picture of how participants feel or function in their daily lives by providing ways of measuring clinical characteristics or clinical events (eg, hypertensive events, tremors, or acute hypoglycemia) that would otherwise be unavailable or impractical without the use of DHTs,” the FDA noted.