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GUIDANCE DOCUMENT

Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry June 2019

Draft Level 1 Guidance

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry

Docket Number:
2019-11978
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

Over the past few decades, FDA policy initiatives have focused on promoting enrollment practices that lead to clinical trials better reflecting the population most likely to use the drug if the drug is approved, primarily through broadening eligibility criteria.2 Despite these efforts, challenges to participation in clinical trials remain, and certain groups continue to be 20 unnecessarily underrepresented in many clinical trials. This guidance recommends approaches that sponsors of clinical trials to support a new drug application3 or a biologics license application can take to broaden eligibility criteria, when scientifically and clinically appropriate,  and increase enrollment of underrepresented populations 4 in their clinical trials.5


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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: 2019-11978 .