FDA Draft Guidance for Industry: Considerations for the Design and Conduct of Externally Controlled 1 Trials for Drug and Biological Products1
Title:
FDA Draft Guidance for Industry: Considerations for the Design and Conduct of Externally Controlled 1 Trials for Drug and Biological Products1
Origin/Publisher:
Office of Communication, Outreach and Development Center for Biologics Evaluation and Research Food and Drug Administration 10903 New Hampshire Ave., Bldg. 71, Room 3128 Silver Spring, MD 20993-0002 Phone: 800-835-4709 or 240-402-8010 Email: ocod@fda.hhs.gov https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances
Document Type:
Draft Guidance
Content:
This FDA guidance describes recommendations for sponsors and monitors of clinical trials to demonstrate the effectiveness and safety of a drug. An externally controlled trial is a type of clinical trial that compares the results of participants receiving an investigational treatment with the results of a comparison group that did not receive the same treatment. This comparison group may be drawn from previous treated or untreated subjects (historical control) or from treated or untreated subjects from the same time period but from a different setting (concurrent control).
The guide addresses considerations for the design and analysis of external controlled trials and discusses potential biases that may lead to invalid study results. It will focus primarily on the use of patient data from other clinical trials or real-world data sources such as registries, electronic health records, and medical billing. The guidance also addresses considerations for communicating with FDA and ensuring FDA access to data fr