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# New Guidance Promotes More Trial Diversity
- URL: https://www.fdaweb.com/new-guidance-promotes-more-trial-diversity/
- Published: 2022-04-13T12:00:00.000Z
- Updated: 2026-09-14T17:40:39.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5151580

FDA has published a new draft guidance, *Diversity Plans to Improve Enrollment of Participants from Under-represented Racial and Ethnic Populations in Clinical Trials*, that expands on an earlier guidance intended to help the industry improve clinical trial diversity. The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/diversity-plans-improve-enrollment-participants-underrepresented-racial-and-ethnic-populations?ref=fdaweb.com) says individuals from several named populations are frequently under-represented in biomedical research despite having a disproportionate disease burden for certain diseases relative to their proportional representation in the general population.

“Adequate representation of these populations in clinical trials and studies supporting regulatory submissions helps ensure that the data generated in the development program reflect the racial and ethnic diversity of the population expected to use the medical product if approved, and may potentially identify effects on safety or efficacy outcomes that may be associated with, or occur more frequently within these populations,” the guidance says.

An agency [statement](https://www.fda.gov/news-events/press-announcements/fda-takes-important-steps-increase-racial-and-ethnic-diversity-clinical-trials?ref=fdaweb.com) says the guidance recommends that sponsors of medical products develop and submit a Race and Ethnicity Diversity Plan to the agency early in clinical development, based on a framework outlined in the guidance.

The new draft expands on a 2016 guidance that outlined how to collect and present race and ethnicity data in submissions to FDA and recommended that sponsors develop and submit a plan to address the inclusion of clinically relevant populations for discussion with the agency. “Given the importance of increasing enrollment from historically under-represented racial and ethnic populations, FDA is publishing this guidance to provide detail on what sponsors should include in a Race and Ethnicity Diversity Plan,” it says.