GUIDANCE DOCUMENT

Final

Docket Number: FDA-2019-D-1264 Issued by:

Guidance Issuing Office

Center for Biologics Evaluation and Research

Center for Drug Evaluation and Research

This guidance recommends approaches that sponsors of clinical trials intended to support a new drug application or a biologics license application can take to increase enrollment of a representative population in their clinical trials. This guidance considers both demographic characteristics of study populations (e.g., sex, race, ethnicity, age, location of residency) and non-demographic characteristics of populations (e.g., patients with organ dysfunction, comorbid conditions, disabilities, those at the extremes of the weight range, and populations with diseases or conditions with low prevalence). Enrolling participants with a wide range of baseline characteristics may create a study population that more accurately reflects the patients likely to take the drug if it is approved and allow assessment of the impact of those characteristics on the safety and effectiveness of the study drug.

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All written comments should be identified with this document’s docket number: FDA-2019-D-1264.