Real-World Evidence Webinar Series:
Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products Draft Guidance for Industry
April 13, 2023, 2-3 PM ET
The Reagan-Udall Foundation for the FDA, in collaboration with the Food and Drug Administration (FDA), hosted a free, public webinar as part of a series of webinars for FDA-issued guidance related to real-world evidence (RWE). The webinar to discuss the FDA-issued draft guidance entitled “Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products” was held on April 13 from 2-3 PM ET. Webinar attendees had an opportunity to hear from the FDA during the session as well as submit questions when registering for the webinar.
This draft guidance provides recommendations to sponsors and investigators on the use of externally controlled clinical trials to provide evidence of the safety and effectiveness of a drug or biologic. Although various sources of data can serve as the control arm in an externally controlled trial, this guidance focuses on the use of patient-level data from other clinical trials or from real-world data sources such as registries, electronic health records, and medical claims.
The FDA issued this draft guidance as part of a series of RWE guidance documents to help satisfy, in part, a mandate under the Federal Food, Drug, and Cosmetic Act; the guidance also meets a Prescription Drug User Fee Act commitment to issue guidance about the use of RWE in regulatory decision-making.
To ensure that the Agency considers comments before working on the final version of this guidance, electronic or written comments on the draft guidance may be submitted to the assigned docket by May 2, 2023; more information on submitting comments to the FDA is available here.
This webinar is part of a series hosted by the Reagan-Udall Foundation for the FDA, in collaboration with the U.S. Food and Drug Administration (FDA). This series is supported by the FDA of the U.S. Department of Health and Human Services (HHS) as part of an award of $56,097 in federal funds (100% of the project). 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. For more information, please visit FDA.gov.