Will Pharma Continue Efforts to Diversify Clinical Trials?

In the first month of the new administration, President Trump sent a clear message: Diversity, equity, and inclusion (DEI) initiatives across the federal workforce would be terminated.

While these anti-DEI initiatives have largely targeted hiring practices, they also have scrutinized programs and guidance on increasing diversity in clinical trials. Within the first week of the new administration, the US Food and Drug Administration (FDA) webpages on promoting diversity in clinical trials went offline.

Building more inclusive clinical trials has become an increasing priority for clinical research to improve the generalizability of study results and better understand treatment efficacy across different patient populations. Given these benefits, these efforts will likely continue, said Doug Peddicord, PhD, executive director of the Association of Clinical Research Organizations in Washington, DC.

“Not only [do] regulators but sponsors and CROs and others involved in the conduct of clinical trials increasingly recognize the recruitment of representative populations as basically good science, good ethics, and good business,” he told Medscape Medical News.

Other experts, however, are more skeptical.

“Research shows that pharmaceutical companies do not fully internalize the benefits of patient diversity for future drug demand,” said Marcella Alsan, MD, MPH, PhD, a professor of public policy at the Harvard Kennedy School in Cambridge, Massachusetts. Her research focuses on the economics of health inequality. “Without government incentives or regulation, firms may be less likely to invest in diverse trials,” she said.

Removal of FDA Diversity Pages

Days after a number of executive orders reversing previous policies on DEI initiatives, draft guidance on diversity action plans to improve enrollment of historically underrepresented groups in clinical trials was removed from the FDA website. The guidance document re-appeared as of 11:59 PM on February 11, 2025, “per court order,” according to a highlighted statement now on the webpage.

“Any information on this page promoting gender ideology is extremely inaccurate and disconnected from the immutable biological reality that there are two sexes, male and female,” the FDA statement reads.

The guidance itself is primarily focused on ensuring “adequate representativeness of study participants that reflect different age groups, sexes, and racial and ethnic demographic characteristics,” the document states. However, as applicable, the guidance encourages considering other factors such as gender identity, sexual orientation, socioeconomic status, and physical and mental disabilities.

A webpage for Project Equity, a program by the FDA’s Oncology Center of Excellence aimed at increasing diversity in cancer trials, was also removed and remained down as of February 25.

Industry Confusion

The removal of the diversity action plan guidance raises questions about what the FDA expects for ongoing and future clinical trials, said Lindsay McNair, MD, MPH, the principal consultant at Equipoise Consulting in Allston, Massachusetts, and an adjunct associate professor at the Boston University School of Public Health, Boston.

“Sponsors are in the dark about whether or not they’re still supposed to submit those [diversity action] plans,” she said.

“I think everyone working [in] research still understands that you will have the best rigor in your studies when you make sure that the population you’re studying represents the eventual [patient] population,” McNair continued. That understanding is “still there, just the details of how to do that and what’s expected of that data are what’s missing now.”

While the removal of the guidance did cause some concern about what this could mean for future research, Peddicord emphasized that anti-DEI efforts will likely not deter efforts to diversify clinical trials.

“At this point, if it’s clear that it makes for better science, and if it’s clear that it makes for better business, I’m not sure why you would retrench on those efforts,” he said.

Alsan, however, noted that pharmaceutical companies “they tend to underinvest in accrual of diverse samples.” This reduced focus on diversity efforts by regulatory bodies could worsen underrepresentation in future clinical trials, she said. “Underinvestment in diverse trials has been associated with lower adoption of new treatments among underrepresented populations,” she explained.

Looking Forward

In a statement, the biopharmaceutical company Merck, based in Rahway, New Jersey, reiterated its commitment to diversity in clinical trials: “There are both scientific and business reasons to enroll participants into clinical trials that reflect the broad populations of people our medicines and vaccines are designed to treat and protect. Our position remains unchanged.”

Genentech, a biotechnology company based in San Francisco, said it is evaluating the situation. “Given the highly dynamic policy environment, we are taking time to understand any potential implications of executive orders and other actions by the new administration. We will continue to watch the legal and regulatory landscape to ensure we remain compliant with all local laws,” the statement said.

Pfizer, Gilead, and Johnson & Johnson did not respond to requests for comment on whether the removal of the FDA draft guidance will affect these companies’ efforts to build more diverse clinical trials.

Peddicord believes that, at least for now, efforts to design more representative clinical trials will continue. However, the future of the draft diversity action plan guidance remains less certain.

Robert F. Kennedy Jr, now the head of Health and Human Services, stated during his confirmation hearing that he would finalize the guidance, which was due to be finalized by June 2025. When asked for comment on finalizing this guidance, an FDA spokesperson said the agency had no information to share.

“We’ve seen guidance before [that remains] in draft for many years; we’ve seen guidance [that is] finalized and then reissued, and then re-finalized,” Peddicord said. “There are lots of things that can happen.”

Alsan, McNair, and Peddicord had no disclosures.