Enhancing the Diversity of Clinical Trial Populations - Eligibility Criteria, Enrollment Practices, and Trial Designs - new FDA Draft Guidance for Industry

Enhancing the Diversity of Clinical Trial Populations - Eligibility Criteria, Enrollment Practices, and Trial Designs - new FDA Draft Guidance for Industry 

Today the U.S. Food and Drug Administration (FDA) issued a draft guidance titled Enhancing the Diversity of Clinical Trial Populations - Eligibility Criteria, Enrollment Practices, and Trial Designs. This draft guidance provides recommendations for more inclusive trial practices, trial designs, and methodological approaches sponsors can take to broaden eligibility criteria and increase enrollment of more diverse populations in clinical trials. Broadening eligibility criteria, when appropriate, maximizes the generalizability of trial results and the ability to understand the therapy’s benefit-risk profile across the patient population likely to use the drug in clinical practice, without jeopardizing patient safety. The draft guidance reflects FDA policy encouraging inclusion in clinical trials of participants representative of the broad population of patients who will be exposed to a marketed drug and is being issued to satisfy the FDA Reauthorization Act of 2017 (FDARA) mandate.

Comments on this draft guidance will be collected for 60 days following publication through the related docket (FDA-2019-D-1264).