The Impact of DEI Ban On Clinical Research Ecosystem

Rebecca Johnson, PhD, Clinical Research Recruitment and Inclusion Executive and Strategist

Efforts to make sustainable change toward more inclusive clinical research have gained momentum in recent years. The enactment of legislation through the Food and Drug Omnibus Reform Act of 2022 (FDORA), which requires sponsors to submit diversity action plans (DAPs) for pivotal studies, highlights this commitment.¹ Industry sponsors are making concerted efforts to ensure trial populations reflect the diversity of the populations they aim to treat, ensuring research is more inclusive and accessible.² In addition to race and ethnicity, clinical trial diversity efforts are now increasingly focusing on other factors that characterize populations often underrepresented in clinical research, such as sexual orientation, gender identity, socioeconomic status, and age, among others.³

However, the recent executive orders (EOs) by the Trump administration banning all US diversity, equity, and inclusion (DEI) and gender identity initiatives in the federal government have consequently impacted clinical trial diversity, putting in jeopardy programs designed to promote equitable access, particularly for LGBTQIA+ populations and other groups underrepresented in research.^4-8 This development raises critical questions about what clinical trial diversity-related initiatives and programs are still “allowable” under the new policies.

If clinical trial diversity continues to be caught in the crossfire of the DEI ban, it could have significant repercussions for drug development.

Consequences for R&D

It is well documented that the failure to achieve appropriate representation in clinical trials limits the generalizability of results and hinders understanding of drug response variability across different subgroups.⁴ Without inclusive recruitment, sponsors risk delays and higher costs—either through slowing enrollment or the need for postmarketing studies.^9,10 Public trust in an approved treatment, among both physicians and patients, is crucial for widespread adoption. For example, physicians treating Black patients are less likely to prescribe drugs approved based on unrepresentative trials, while Black patients are more likely to trust a drug that was studied in a trial representative of participants in their racial group.¹¹

Specifics of executive orders

The EOs titled “Ending Illegal Discrimination and Restoring Merit-Based Opportunity” and “Ending Radical and Wasteful Government DEI Programs and Preferences” mandate the termination of all “diversity,” “advancing equity,” and “diversity, equity, inclusion, and accessibility” principles, programs, positions, and workforce balancing in federal agencies, contractors, and grantees.^6,7 These EOs also seek to deter DEI programs within the private sector.⁶ The Department of Justice will “investigate, eliminate, and penalize illegal DEI (and accessibility) preferences, mandates, policies, programs, and activities in the private sector.”¹²

The EO titled “Defending Women from Gender Ideology Extremism and Restoring Biological Truth to the Federal Government” prohibits the recognition of gender identity apart from biological sex.⁸

While specifics related to what constitutes a DEI program are not outlined in the EOs, Diversio, in a report released in February, conducted an analysis of the recent directives published by the administration and deemed the following practices, among others, as “illegal DEI”:

• Race-based or gender-based quotas for hiring or promotions.¹³
• Training or messaging that focuses on addressing privilege, implicit bias, systemic inequalities, or oppression based on race or gender.¹³

The Trump administration’s actions have led to a banned word list, including terms such as “disability,” “inclusion,” “excluded,” and “racism.”¹⁴

Multi-stakeholder perspectives

The clinical trial ecosystem includes various stakeholders, such as community members, clinical research sites, contract research organizations, academia, advocacy organizations, government agencies, and sponsors. If executive actions continue as currently outlined, government contractors and the private sector will be impacted, with many stakeholders at risk of violating federal laws if their DEI practices conflict with new policies. Implications of the DEI ban are explored ahead from a multi-stakeholder perspective across the clinical trial ecosystem.

Patients: Will efforts to build trust in the medical system be disrupted?

Mistrust in the medical community is a prominent barrier to clinical research participation. Clinical research stakeholders have made significant strides to help build trust, with efforts such as establishing long-term community relationships and providing summary information after a trial. The hyper-focus on anti-DEI initiatives and publicity surrounding anti-immigration and gender identity sentiments threatens to undermine trust, especially among Hispanic and sexual and gender diverse (SGD) populations.¹⁵

Paul Evans, CEO of Velocity Clinical Research, an integrated site organization, commented, “Velocity believes that clinical trials should be a safe space for the entire LGBT community. Right now, there seems to be a heightened focus on the ‘T’ part, and I am concerned about how an emphasis on ‘transgender’ could potentially create a negative perception. It’s important that all members of the LGBT community feel welcome, regardless of their specific identities. If participants feel excluded or unwelcome, it could affect the broader community’s trust. We should ensure that Velocity remains a place where everyone, from all parts of the LGBT spectrum, feels respected and included.”

It appears that, for patients, pharmaceutical companies’ efforts to publicly share information about employing diverse staff are important. A 2023 study by the Center for Information and Study on Clinical Research Participation (CISCRP) found that diverse staffing in pharma companies boosts trust among Black and Hispanic patients.¹⁶ Similarly, patients trust providers who “look like me.”¹⁷

As sponsors and health systems scale back their diversity hiring practices, they should be mindful that transparency and representativeness mean a great deal to patients.

Healthcare providers: What is the outlook for future researchers and the opportunity to reach patients for trial participation?

After declaring racism a public health emergency in 2020, health systems announced DEI and health equity initiatives to improve access to care and employ a workforce that better reflects community demographics.^18,19 However, backlash against these initiatives is growing. For instance, Cleveland Clinic faced a civil rights complaint in 2024 over services tailored for Black and Latino patients.²⁰

Health systems and medical colleges, published reports note, appear cautious and have refrained from commenting on their future DEI plans.¹⁹

DEI programs, such as those at Mount Sinai, support many populations often underrepresented in the healthcare system, including veterans, disabled patients, and those who identify as SGD.²¹ The ramifications of the executive orders on these programs are unclear.²²

The cuts by the National Institutes of Health (NIH) to indirect expenses provided to research grants will impact academic medical centers that rely on these funds to support their research infrastructure.²³

According to the Associated Press, federal funds supply the largest source of research dollars for Duke University, and these cuts could hinder research as well as the pipeline for the next generation of researchers. Findings published in journals such as The American Journal of Bioethics and PLOS Global Public Health note that Black, Hispanic, and Indigenous physicians are already underrepresented not only in the healthcare workforce but also as researchers.^24,25 Anti-DEI efforts could further widen this gap.²⁵

Stymieing programs that promote access to care and a diversified pipeline of future researchers will directly impact clinical research.

Research sites: Can they uphold community engagement and staffing?

Effective inclusive recruitment practices reported by research sites include hiring staff who reflect the communities they partner with and who speak the same language.²⁶ In fact, the diversity of patients enrolled at a site is proportionate to the diversity of the site personnel.²⁷ Many research sites, such as academic medical centers, rely on research grants, and the reduction in funding may have a negative effect on staffing as well as community engagement programs that are critical for raising awareness and building trusting relationships.

The outlook may be more positive for private sites and private site organizations. At Velocity Clinical Research, Evans said it uses a three-pronged approach: recruiting diverse staff representative of their patient population; ensuring access (they even physically moved some sites) and actively engaging communities.

“Our staff reflects the population and we track metrics,” explained Evans. “Staff at Velocity are representative of the US Census and our sites are representative. We are going to keep carrying on doing that. The staff has to be representative of the population they are recruiting. I think everyone gets hung up on affirmative action.

“My grandmother always told me some things are just right and wrong,” he continued. “All we’ve ever tried to do is make sure we are a welcoming company and we recruit widely. That happens to be right. I’ve never set a quota in my life.”

Training research staff is an important component for cross-cultural recruitment.²⁸ Study teams may lose important training on addressing the historical legacy of injustice and systemic racism, which contribute to institutional distrust among many underrepresented populations. Investigators and healthcare professionals have expressed a need for improved skills in cross-cultural communication across the many dimensions of diversity.^28,29 Important components of such training include topics such as biases, stigmatization, and discrimination—themes that are now prohibited under the new policies.²⁹

Payers: Coverage decisions remain the same, but barriers may persist

Managed care experts have indicated that payers are unlikely to change the way they review clinical trial data for their formulary decision-making. Payers need to see efficacy in populations that match the disease burden when formulary decisions are evaluated. If trial participants do not reflect a payer’s membership demographics, coverage may be restricted to the demographics represented in the study, potentially limiting access to effective treatments and disenfranchising individuals who could benefit from it.

Payers are scaling back their DEI initiatives in other areas. According to Modern Healthcare, 2024 annual reports from the largest health insurers show changes to their DEI strategies.³⁰ While some organizations have stated they are not altering their DEI policies, references to DEI have been scaled back and replaced with more “neutral” language in their reports.³⁰

While these changes seem to be limited to workplace DEI initiatives, they have a ripple effect. For example, as Modern Healthcare notes,Cigna removed the following statement from its report: “We also help to eliminate barriers to care and address other factors that contribute to health disparities.”³⁰ If programs aimed at improving access to care are deprioritized, it could result in fewer visits to physicians, limiting opportunities for patients to learn about clinical trials—thus exacerbating existing barriers to clinical trial diversity.

Sponsors: Balancing compliance with diversity and inclusion in trial goals

Since the COVID-19 pandemic and the heightened focus on ensuring representation of historically underrepresented populations in COVID vaccine trials, pharmaceutical companies have expanded their efforts to ensure diverse representation in their clinical trials. Eli Lilly, for example, announced plans to shift toward predominantly conducting community-oriented research.³¹ Through another initiative called Equitable Breakthroughs in Medicine Development, which is funded by a grant from Pharmaceutical Research and Manufacturers of America, sponsor companies are working with community sites and partners to build an infrastructure of community-based sites.³²

With the changing legislative requirements, many pharmaceutical companies are adjusting their policies and messaging regarding DEI initiatives. In its annual report, GSK stated, “Going forward, we will make changes in several areas related to inclusion and diversity to ensure continued compliance with the law and being respectful of our operating environment, including no longer setting aspirational targets for our leadership.”³³ Pfizer updated its DEI webpage to reflect a commitment to merit-based hiring practices while ensuring it recruits the best talent from all backgrounds.³⁴

When asked if clinical trial diversity efforts would be impacted by the regulatory changes, a VP of clinical operations for a biopharmaceutical company shared the following regarding its research that relies on public-private partnerships, “I do. Mainly because academic institutions will likely be impacted, which will increase our cost of doing business. Part of the reason is the proposed cut of indirect costs. High costs of specialty vendors that may specialize in recruitment of underrepresented people will have a downstream impact.”

Despite this, industry experts believe pharma companies are continuing their efforts to achieve more representative trials. “We are still writing the DAP, even though it’s not mandated right now. We are still staying the course,” the VP of clinical operations mentioned.

It is widely agreed that trial populations need to reflect the epidemiology of the disease being studied. “Variability of drug response is what we’re going after—assume there is a difference until proven otherwise,” noted the pharma executive. “The social issue is a construct people have made and have added complexity to this topic.”

Among pharma sponsors, the focus on ensuring representative trial populations is expected to continue despite the new regulations.

Healthcare system: Is there enough incentivization to continue public health initiatives?

A visible shift in research priorities is evident, with funding for health equity and diversity and inclusion programs cut across numerous federal agencies.^5,14 The NIH All of Us Research Program plays a key role in advancing public health research and rebuilding trust in science and research. Yet, funding cuts necessitate the need to revise program priorities such as engaging rural populations.³⁵ These cuts will reduce efforts to engage historically underrepresented communities and could hinder progress in research diversity.

One goal of Healthy People 2030 is to eliminate health disparities, achieve health equity, and attain health literacy to improve the health and well-being of all.³⁶ Another goal is to improve the health, safety, and well-being of lesbian, gay, bisexual, and transgender people. However, a disclaimer now appears on the Healthy People webpage indicating that the content has been rejected.³⁷ Given that language previously considered acceptable is now deemed “illegal,” it raises concerns about which public health initiatives will remain intact. These public health initiatives play a critical role in building trust in the healthcare system, which is essential for fostering participation in clinical research.

In 2018, racial and ethnic health disparities reportedly cost the US economy $451 billion.⁵ Findings from a recent study by the National Academies of Sciences, Engineering, and Medicine estimated that achieving even modest diversity in research could reduce health disparities, resulting in billions of dollars in savings to the US economy.³⁸

If public health initiatives are scaled back, reducing health disparities may become more difficult, and clinical trials may become less representative, undermining progress toward equity.

Policy: Navigating conflicting messaging and understanding regulatory expectations

Clinical trial regulators must address conflicting mandates and clarify expectations.

The FDA’s stance on DEI in clinical trials remains supportive, as evidenced by the agency’s commissioner nominee Marty Makary’s confirmation hearing comments: “I believe in common sense, and I believe in clinical trial diversity,” he said. “If you’re going to make results extrapolated to the general population, you should have results in those populations that you’re making recommendations for.”³⁹ However, Makary did not commit to restoring the FDA’s Office of Minority Health and Health Equity website.39

FDA recently removed and re-added DAP guidance with a disclaimer rejecting content on gender identity, citing “biological reality.” DAPs are a statutory requirement under FDORA, and final guidance is expected by June 2025. It remains unclear whether the EOs will impact clinical trial diversity mandates under FDORA.

The FDA’s draft guidance recommending that sponsors investigate potential sex-specific and gender-specific differences for the intended effect of medical devices, released in January 2025, was also removed.⁴⁰ The guidance was set forth because of the lack of data on underrepresentation of nonbinary, transgender, and other gender identities as “gender was often conflated with sex or otherwise not properly reported in clinical studies.”⁴¹

The ambiguity surrounding these issues raises concerns in the clinical research community. The biopharma company VP of clinical operations I spoke with stated, “People are still in shock, not knowing what will happen next. DEI efforts taken in the course of clinical trials may have been taken out of context by the administration. There will likely be a course correction.”

Reframing the conversation

In the meantime, the industry should continue moving forward. Efforts to diversify clinical trials have grown significantly, even without FDA mandates. The clinical trial ecosystem has taken responsibility for improving representation, and made themselves accountable, but clear guidance is needed to align expectations. Based on the current regulatory landscape, here are suggestions for staying the course and reframing the conversation:

• Use terms such as “comprehensive representation” or “representation in research” instead of DEI. Focus on population-reflective studies and set goals based on disease epidemiology.
• Revise training programs to emphasize cross-cultural communication, cultural awareness, and the history of consent failures in clinical research, with careful attention to language.
• Be transparent about research objectives and clearly communicate how each individual’s involvement contributes to the success and impact of the study, emphasizing the value of participation.
• Develop new metrics to explore other dimensions of diversity. When appropriate, consider social determinants of health variables, which may have a more significant impact on outcomes than using race or ethnicity as proxies.⁴²
• Leverage artificial intelligence (AI) for participant selection and the generation of representative trial data. The growing use of AI in clinical research can improve efficiency and accelerate drug development, offering novel approaches to ensure trials more accurately reflect the intended population.⁴³

Advancing and adjusting

Despite the setbacks, stakeholders across the clinical trial ecosystem are dedicated to advancing diversity in drug development, and will adapt as necessary to continue making headway. By reframing the conversation as needed, clinical research professionals can maintain their momentum and perhaps achieve even more comprehensive representation than before. While the terminology may change, our collective resilience will ensure that the goal of accessible and inclusive clinical research remains within reach, no matter what we call it.

Rebecca Johnson, PhD, is a clinical research recruitment and inclusion executive and strategist. In her most recent role, Johnson led the clinical trial recruitment and diversity, equity, and inclusion functions at SPARC. Prior to that, she held several leadership positions within IQVIA’s patient recruitment team, including advising pharmaceutical sponsor teams with their efforts to achieve more diverse trial populations. Johnson has a Master’s in Public Health and a PhD in Health Sciences. Her doctoral dissertation research focused on increasing access to clinical trials for historically underrepresented populations.

References

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