By Andrew Erickson | Alaniz Health
Clinical trial diversity has been a crucial focus in recent years, with initiatives designed to ensure that underrepresented populations have equitable access to participation in medical research. However, recent executive orders (EOs) issued by the Trump administration in early 2025 have sparked confusion and concern among clinical trial principal investigators and project managers, particularly regarding the removal of FDA guidance on diversity from its website.
On February 11th, the FDA’s draft guidance on diversity action plans was partially restored on the FDA website per court order, along with the following message rejecting gender ideology:
“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.”
We know that under the new administration, gender identity and diversity initiatives are being challenged and reversed. But what does that mean for the future of clinical research and clinical research diversity efforts?
As industry professionals dedicated to meaningful research, understanding the implications of the political actions under the new administration is paramount.
A Brief History of the FDA’s Commitment to Clinical Trial Diversity
The FDA has long recognized the importance of diversity in clinical research, with efforts dating back decades to address the underrepresentation of racial and ethnic minorities in drug and device trials. In 2012, the FDA Safety and Innovation Act (FDASIA) mandated that the agency evaluate the inclusion of demographic subgroups in clinical trials. By 2020, the agency had released specific guidance encouraging sponsors to develop Diversity Action Plans to ensure broader participation. The 2022 Food and Drug Omnibus Reform Act (FDORA) further solidified these requirements, mandating formal Diversity Action Plans for pivotal clinical studies. These efforts aimed to improve the generalizability of clinical research data, ensuring medical treatments were effective for all populations.
Sweeping Policy Reversals: What Has Changed?
In January 2025, President Trump signed a series of executive orders aimed at dismantling federal diversity, equity, and inclusion (DEI) programs. These orders called for the elimination of any policies, programs, and guidance perceived as preferential treatment based on race, gender, or identity.
Shortly thereafter, the FDA removed its draft guidance on Diversity Action Plans from its website, which has since been restored. This guidance, originally mandated under the Food and Drug Omnibus Reform Act (FDORA) in 2022, outlined the framework for ensuring diverse clinical trial participation.
The uncertainty stemming from the current political environment raises critical questions:
Will sponsors still need to submit Diversity Action Plans?
What will this mean for research funding tied to diversity initiatives?
FDA’s Silence: A Cause for Concern
While the FDA has not explicitly stated that diversity requirements are being repealed or what might be changed, the removal of guidance documents without formal notice was highly unusual.
Historically, draft guidance has provided a clear indication of regulatory expectations, even before finalization. Despite partially restoring the draft guidance, the agency’s silence has left many researchers uncertain about how to approach diversity planning in their ongoing and upcoming trials.
The Ripple Effect: Clinical Trial Funding and Compliance
For research teams that have worked diligently to improve diversity in clinical trials, the biggest concern is whether the lack of FDA guidance will affect funding and compliance. Many pharmaceutical companies and research institutions have already built Diversity Action Plans into their protocols, anticipating that the FDA would enforce these measures in 2025. If the FDA no longer emphasizes diversity, will sponsors continue investing in diverse recruitment strategies, or will they shift resources elsewhere?
According to Roxanne Alaniz, Founder of Alaniz Health, “Clinical trial diversity is not just a regulatory checkbox, it’s a moral and scientific imperative. Executive actions and FDA guidance do not change the fact that diverse populations experience diseases differently. Our commitment to good clinical research must persist, regardless of shifting political winds.”
Proactive Steps for Clinical Researchers Amid Regulatory Uncertainty
Despite these regulatory uncertainties, clinical trial investigators and project managers should remain steadfast in their diversity efforts. Here’s what you can do:
- Continue Implementing Diversity Action Plans – Even if the FDA does not currently require them, maintaining diversity in your clinical trials strengthens research outcomes and demonstrates proactive commitment to inclusive science.
- Monitor Regulatory Updates – The FDA may issue revised guidance or clarification in the coming months. Keep close watch on regulatory developments.
- Strengthen Industry and Community Partnerships – Work with advocacy groups, patient communities, and marketing partners like Alaniz Health to sustain diversity efforts.
- Educate Sponsors on the Value of Diversity – Highlight how diverse participant pools enhance the applicability of clinical research findings.
A client from a leading neuroscience research organization shared their perspective: “We cannot afford to backtrack on diversity in clinical trials. Our responsibility is to conduct research that benefits all patients, not just a select few.”
Defending Diversity in Clinical Research: The Road Ahead
While the political landscape may shift, the mission of clinical trial diversity remains unchanged. As industry professionals, we must remain advocates for equitable research and continue fostering trust among underrepresented communities. Alaniz Health remains dedicated to supporting research teams in overcoming these challenges, ensuring that clinical trials reflect the populations they aim to serve.
For further insights on adapting to these regulatory changes, contact us at Alaniz Health.
