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# Clinical Trial Population Diversity Guidance
- URL: https://www.fdaweb.com/clinical-trial-population-diversity-guidance/
- Published: 2019-06-06T12:00:00.000Z
- Updated: 2026-09-15T01:31:09.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144275

FDA is issuing a draft guidance, *Enhancing the Diversity of Clinical Trial Populations—Eligibility Criteria, Enrollment Practices, and Trial Designs*, to recommend approaches that NDA and BLA clinical trial sponsors can take to broaden eligibility criteria, when scientifically and clinically appropriate, and increase enrollment of underrepresented populations in their trials. A *Federal Register* [notice](https://s3.amazonaws.com/public-inspection.federalregister.gov/2019-11978.pdf?ref=fdaweb.com) says the document reflects the agency’s policy encouraging inclusion in clinical trials of participants representative of the broad population of patients who will be exposed to a marketed drug. Issuance of such a guidance was called for under the FDA Reauthorization Act.

The guidance provides recommendations: 

- for more inclusive trial practices, trial designs, and methodological approaches sponsors can take to broaden eligibility criteria for clinical trials;
- on approaches sponsors can take to improve the diversity of enrolled participants in clinical trials by making trial participation less burdensome for participants and by adopting enrollment practices that enhance inclusiveness; and
- on approaches sponsors can take to broaden eligibility criteria for clinical trials of investigational drugs intended to treat rare diseases and to improve the enrollment and retention of participants with rare diseases.