Improving Clinical Trial Diversity in a Time When Diversity is a Bad Word
“Black”
“Woman”
“Disability”
“Diversity”
“Female”
“Gender”
“Race”
“Ethnicity”
According to a lengthy review conducted by The New York Times, these are just 8 of the 197 terms that the current administration has decided are unacceptable when applying for research grants from the National Institutes of Health (NIH) or the National Science Foundation (NSF) (Yourish et al., 2025). Including any of these 197 common terms in an application will result in the application being flagged for review.
On January 25th, 2025, the U.S. Food & Drug Administration (FDA) removed its July 2024 draft guidance—Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies—from its website following Trump’s Executive Order banning all Diversity, Equity, and Inclusion (DEI) programs and prohibiting the federal government from recognizing gender identity as being separate from biological sex (Grossi, 2025).
The guidance in question provided sponsors who conduct clinical trials of drugs, biological products, and devices with basic benchmarks for ensuring that all clinical trials comply with their submission of Diversity Action Plans under section 505(z) and section 520(g)(9) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) as added by section 3601 of the Food and Drug Omnibus Reform Act of 2022 (FDORA). This guidance was in draft form, and there are questions as to whether this guidance will ever be finalized or if what is eventually finalized will bear any resemblance to what currently exists.
The document, along with all other content and documents surreptitiously removed to satisfy Trump’s edict, was restored to the FDA’s website here…with the following disclaimer attached:
Per a court order, HHS is required to restore this website as of 11:59 PM on February 11, 2025. 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 Trump Administration rejects gender ideology and condemns the harms it causes to children, by promoting their chemical and surgical mutilation, and to women, by depriving them of their dignity, safety, well-being, and opportunities. This page does not reflect biological reality and therefore the Administration and this Department reject it (FDA, 2024).
So, what does this mean for the future of research?
It could be disastrous, not only for the minority populations that the push to diversify clinical trials aimed to include, but for the entirety of medical and scientific research in the United States. It has the potential to fundamentally shift research and development away from the U.S. and remove the U.S. from leading the world in these fields.
In the medical space, a recent cross-sectional study found that 354 out of 356 drugs (99.4%) approved by the FDA between 2010 and 2019 received funding at some point from the NIH, averaging $1.44 billion dollars per approval on basic or applied research for products with novel targets or $599 million per approval considering applications of basic research to multiple products (Cleary, et al, 2023).
Cleary also found that NIH contributions to medical research were not less than the funds provided by private entities (read: pharmaceutical companies). This means that while pharmaceutical companies and biologic and device manufacturers contribute significant sums throughout the process, many of these companies rely heavily, at some point, upon federal funding from the U.S. to bring their products to the market.
We must also disabuse ourselves of the belief that the companies that rely so heavily on the federal government for funds will remain stalwart despite the loss of billions in federal funding.
Genentech, for example, wiped its website of past diversity reports from its “Diversity & Inclusion” page (Masson, 2025) and replaced it with a new “Inclusion & Belonging” page, which blithely lists its “Employee Resource Groups,” referred to as “DNA Groups”. Clicking on a group shows a cheery photo of smiling ostensible employees with a one-sentence description of the DNA Group.
Gone are the 24-page annual Diversity & Inclusion reports, such as the 2022 report submitted to the California State Assembly, which lays out detailed plans to reach underrepresented patients, increase diversity in clinical trials, and break through cultural barriers.
And Genentech is not alone.
Pfizer revised the title of their Diversity & Inclusion page to read “Merit-Based Diversity, Equity, and Inclusion: Who We Are.” This is a direct response to the numerous statements made by Trump Administration officials that we need a merit-based system rather than one filled with DEI hires who, according to many members of this administration, “Didn’t Earn It.” Pfizer does, however, maintain its page on diversity in clinical trials. The page they direct to that talks about how diversity and inclusion are prioritized in clinical trials (here) has not been updated in two years.
This isn’t a problem whose impacts are limited to one sector or another—Trump’s Executive Orders affect virtually every aspect of life, from our environment to our entertainment, education, housing, voting rights, and health.
We have seen this before: when faced with the actual prospect of a company’s finances being decimated, companies, their boards, and their shareholders will almost always err on the side of caution, particularly when significant portions of their funding derive from the federal government.
The question before us now:
In an administration that prizes junk science over actual science (for example, forcing the CDC to fund a study to research the multiple-times-debunked link between vaccines and autism), who among the pharmaceutical, biologic, and device manufacturers will stand up for actual science?
Will they choose to honor nearly a decade of commitments to improve clinical trial diversity if doing so results in the loss of federal funds?
That remains to be seen.