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# 6 Ways to Improve Trial Diversity
- URL: https://www.fdaweb.com/6-ways-to-improve-trial-diversity/
- Published: 2022-07-21T12:00:00.000Z
- Updated: 2026-09-14T17:52:54.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5152328

Three Syneos Health executives say there are six things FDA could do to better improve representation in clinical trials. Writing in a *Stat News* online opinion [column](https://www.statnews.com/2022/07/21/6-ways-to-bolster-fdas-guidance-for-diversifying-participation-in-clinical-trials/?utm%5Fcampaign=rss&ref=fdaweb.com), the three praise the agency’s guidances issued over the last 25 years and say the recent 4/2022 guidance is a welcome step forward.

“Released in tandem with a rising, long overdue industry scientific and ethical imperative for more diverse trial participation,” the column says, “the proposed FDA plan has the potential to be a critical propellant for more inclusive research. Within this context of renewed focus on diversity, equity, and inclusion, meaningful and sustainable change should not only be mandatory but achievable. And for the first time, this FDA guidance is prescriptive in clearly telling biotech and pharmaceutical companies to come with a plan to FDA meetings.”

The column gives six ways to enhance what the authors say are the already strong recommendations in the FDA draft guidance to optimize the development of clinical trials that are as diverse and inclusive as possible. They are:

- insist on accountability by moving from “should” to “must” and requiring the development and implementation of enrollment plans centered around increasing diversity for all Phase 2 through Phase 4 trials;
- require sponsors to provide insight into how their understanding of specific healthcare disparities has been integrated into their proposed plans;
- define “diverse population”;
- require that enrollment goals include a description of how they were determined, including quantitative and qualitative assessments that help connect enrollment goals to disease epidemiology;
- set enrollment and retention strategies; and
- set mistrust with a historical context that recognizes the multiple historical sources that have generated earned mistrust.

“Achieving broader diversity, equity, and inclusion in clinical trials requires nothing less than a universal commitment to diverse, equitable, and inclusive research that will lead to better medical treatments for more people,” the authors conclude.