FDA Diversity Action Plans for Clinical Trials Restored
- Sabrina McCrear
- Apr 9
- 3 min read
The Food and Drug Administration (FDA) restored its diversity action plan for clinical trials by Supreme Court order after the Trump administration removed it on Feb. 11 as part of the order to remove diversity, equity and inclusion (DEI) programs from the federal government.
The DAP, titled ’Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies’ ensures clinical trials document different drug responses by sex, race, ethnicity and age, was introduced by the Biden Administration in June of 2022. On Jan. 20, President Trump signed an executive order prohibiting all federal (DEI) programs – requiring the FDA to remove it from its website.
“A lot of the standards of research done hasn’t been reflected for people of color…so these clinical trials and these research studies are very imperative,” said Dr. Rolanda Brown, recent MD graduate, and co-author of the peer-reviewed journal, “The Importance of Diversity in the Healthcare Workforce.”
The FDA annually publishes data on clinical trial participants according to the DAP guidelines. In 2023, they reported that the majority of participants were white. The DAP requirements encourage researchers to pursue alternative methods that will increase underrepresented groups’ participation in clinical trials.
Dr. Ray Dorsey, professor of neurology at the University of Rochester and leader in Parkinson’s disease research, is exploring decentralized trials as an alternative to traditional clinical trials.
“We should be bringing research studies and research opportunities to individuals instead of relying on individuals to come participate in trials,” he said.
Often underrepresented or minority populations face unfair systemic societal barriers. This could include being unhoused, lack of access to medical centers or physical health conditions. These challenges can prevent people from participating in clinical trials even if they meet the necessary criteria.
“The goal is to bring care to patients on their terms and to bring research studies to research participants,” Dorsey said. “We should be reducing their burdens not increasing them.”
He said researchers and physicians of color are also essential to the discussion of increasing minority representation in clinical trials.
“If we want to enhance care for individuals, if we want to enhance research participation, I think it matters who’s providing that care and who’s conducting that research,” Dorsey said.
For example, during Brown’s medical school clinical rotation, she advocated on behalf of a black woman.
Her attending physician initially diagnosed the woman with a tick disorder. However, after Brown consulted the patient, she diagnosed the actual problem.
“I’m like, no. Doctor, her weave is itching,” Brown said. “If I wasn’t there, she would’ve been drugged.”
Situations like the one Brown experienced are common in the medical field. Oftentimes, there are cultural differences that a white doctor may not recognize and mistake for something else.
For example, dated clinical trials measuring high blood pressure standardized angiotensin-converting enzyme inhibitors (ACE) or angiotensin receptor blockers (ARB)—which block the production of angiotensin II, a hormone that controls blood pressure—for everyone.
However, a recent study published in the Journal of the American Board of Family Medicine suggested ACEs and ARBs are less successful at managing HBP in some black individuals than a thiazide diuretic.
According to the National Institute of Health, a thiazide diuretic more commonly known as a ‘water pill’ helps the kidneys eliminate sodium and fluid from the body. Which, in turn, widens your arteries thus lowering your blood pressure.
Dr. Brown emphasized the importance of having guidelines and standards that reflect the black population.
“No two persons are the same, what treatment might work for one person may not work for another,” she said.
DEI initiatives were one of the first programs President Trump cut on his first day in office. In just the first two months in office, Trump is continuing to remove any reference of DEI terms in any federal agency.
Brown works closely with her church to provide fresh fruits and vegetables to locals in need. Although the service is not clinical, she sees it to spread awareness and encourage healthy lifestyles in underrepresented communities.
“These little local efforts are having a vast effect on long-term health outcomes of the community,” she said. “Even if it’s a small community, that small effort can make an impact.”
