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# Steps FDA Could Take to Increase Trial Diversity
- URL: https://www.fdaweb.com/steps-fda-could-take-to-increase-trial-diversity/
- Published: 2022-03-09T12:00:00.000Z
- Updated: 2026-09-14T17:35:52.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151324

A Trinity Life Sciences online white paper says that while most of its recommendations for increasing the diversity of participants in clinical trials involve patients and drug companies, “diversity in clinical trials cannot be accomplished without coordinated efforts of clinical trial sites and overseeing regulatory bodies or sponsors.” The [paper](https://trinitylifesciences.com/wp-content/uploads/2022/02/Trinity-Whitepaper-Diversity-in-Clinical-Trials-Participation.pdf?ref=fdaweb.com) says that Black Americans are about 13% of the population but make up only 5% of clinical trial participants. Hispanic and Latino patients are about 19% of the population, and constitute only about 1% of clinical trial participants, it says.

“Despite these disparities in representation,” Trinity says, “FDA has not instituted any minimum requirements around representation.” The firm recommends that the agency institute specific policy requirements on representative recruitment for clinical trials. “Ideally,” it says, “these policy changes would not only reflect the makeup of the general population, but also consider the racial, ethnic, and gender makeup of the specific disease.”

Trinity says that one result of such a change would likely be to make clinical trial recruitment slower and more onerous, potentially stretching out the timelines to reach medication approval.

“It may be helpful for FDA to have a centralized database where patients can sign up for clinical trial consideration as soon as they are diagnosed with a condition,” the paper says. “This would help doctors to reach patients more easily and potentially target recruitment to specific racial, ethnic, or gendered groups who are still needed to meet these FDA requirements.”