Statistical Considerations for Digitally-Derived Endpoints in Clinical Trials

Join the Food and Drug Administration (FDA) for a virtual public workshop, convened by the Duke-Margolis Institute for Health Policy under a cooperative agreement with the FDA, to discuss statistical considerations for digitally-derived endpoints in clinical trials for drug and biological products. Speakers will provide updates on FDA efforts under PDUFA VII to advance the use of digital health technologies (DHTs) in drug development and regulatory review. Discussions will also explore opportunities to strengthen data standards and innovative analytical methods that support the broader use of clinically meaningful, digitally-derived endpoints in clinical trials for drug and biological products. Speakers will also discuss the Submitting Continuous Glucose Monitoring Data in Clinical Trials Technical Specifications Document to provide foundational background for regulatory submissions for drug and biological product evaluation, device performance assessment, and analytical best practices.

Funding acknowledgment:

This event is supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award U01FD008451 totaling $1,399,999 with 100 percent funded by FDA/HHS. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA/HHS, or the U.S. Government.