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# FDA Manuscript in the Works on Trial Diversity Strategy
- URL: https://www.fdaweb.com/fda-manuscript-in-the-works-on-trial-diversity-strategy/
- Published: 2022-12-08T12:00:00.000Z
- Updated: 2026-09-14T18:08:58.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5153358

FDA is preparing a manuscript to outline a strategy for getting more diversity into clinical trials, commissioner **Robert Califf** said 12/7 during a plenary session at the Milken Institute’s Future of Health Summit in Washington, DC. Improving trial diversity is a top focus of the agency, and earlier this year it released a draft guidance on industry developing plans to enroll more participants from underrepresented racial and ethnic populations in the U.S. into clinical trials.

Califf told the conference that some progress is being made. “If you look at the NIH-funded clinical trials right now, they look pretty good. “If you look at the [drug snapshots](https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots?ref=fdaweb.com) from FDA, it’s gotten better. There are many more complex issues. But right now, we really need to focus on solidifying and improving the gains we’ve made with regard to the standard age, sex, race, ethnicity, gender, those demographic characteristics where we know we can do better.” He also said diversity in the geography is very important, such as rural people, particularly the elderly, which means “more trials done at home, and more distribution of the technology.”

Califf said it is “asking a lot of a clinical trial system to overcome a health system which is structurally configured to create these disparities in the first place. So, what I'm hearing from clinicians out there is they would love to do some of this stuff, but they’re not being encouraged to do it by the administrators that they work for these days. So as we think about this we have to realize clinical research doesn't happen in a vacuum, and it’s happening in the context of the health system that we’re in and there’s going to need to be progress in the health system if we are going to get to where we need to be.”

The draft guidance released earlier this year, “[Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Subgroups in Clinical Trials](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/diversity-plans-improve-enrollment-participants-underrepresented-racial-and-ethnic-populations?ref=fdaweb.com),” recommends that sponsors develop and submit a Race and Ethnicity Diversity Plan to the agency early in clinical development, based on a framework outlined in the document. It says barriers to participation among racial and ethnic groups “may include mistrust of the clinical research system due to historical abuses, aspects of the trial design such as inadequate recruitment and retention efforts, frequency of study visits, time and resource constraints for participants, transportation and participation conflicting with caregiver or family responsibilities. In addition, language and cultural differences, health literacy, religion, limited access within the health care system and a lack of awareness and knowledge about what a clinical trial is and what it means to participate may impact clinical trial participation among racial and ethnic minority populations.”

To view Califf’s 30-minute presentation, click [here](https://milkeninstitute.org/video/rob-califf-future-health-summit?ref=fdaweb.com).