FDA Removed Diversity Action Plan Guidance, but Its Purpose is as Strong as Ever

As of February 11th, 2025, FDA Guidance on Diversity Action Plans has been restored by court order, but now includes a memo from the Trump Administration to disregard information that it might pertain.

In the dynamic landscape of clinical research, the U.S. Food and Drug Administration (FDA) recently made headlines by removing its guidance on Diversity Action Plans for clinical trials. For many, this decision appears as a step backward, particularly at a time when the importance of diversity, equity, and inclusion (DEI) initiatives is being questioned in the broader political sphere. However, for those of us in the clinical trials field, the commitment to diversity is not just about meeting guidelines—it’s about better science, improved patient outcomes, and equitable healthcare access. While the official guidance may have shifted, the purpose behind diversity action plans remains as critical as ever.

Diversity: Beyond Ethnicity

When discussing diversity, the conversation often defaults to ethnicity or race. These aspects are certainly vital, especially when we consider the historical underrepresentation of many communities in clinical trials. More directly, ethnicity has biological impact due to genetics and condition prevalence within those communities. However, diversity encompasses so much more. 

According to the Food and Drug Omnibus Reform Act (FDORA) of 2022 and the original FDA guidance, diversity also includes:

• Age: From pediatric to geriatric populations, age-related factors can significantly influence how patients respond to treatments.
• Gender and Sex: Men and women, and individuals across the gender spectrum, may experience different outcomes or side effects from the same intervention.
• Socioeconomic Status: Income, education level, and access to healthcare can impact participation and outcomes.
• Geographic Location: Urban versus rural populations may face unique healthcare challenges and opportunities.
• Comorbidities: Patients with additional health conditions often experience treatments differently compared to those without.
• Cultural and Linguistic Differences: These factors can influence how patients perceive and interact with healthcare systems and research teams.

By broadening the definition of diversity, we open the door to truly inclusive and representative clinical trials—an essential step toward equitable healthcare outcomes. All these measures of diversity factor into the efficacy of studies, sometimes more greatly than ethnicity or race alone.

Why Diversity in Clinical Trials Still Matters

While the FDA’s shift away from explicit Diversity Action Plan guidance might tempt some stakeholders to deprioritize diversity in their clinical trial designs, this would be a grave mistake. Here’s why diversity remains paramount:

1. Better Science: Clinical trials with diverse populations produce data that better reflects the real-world population. This leads to more accurate findings about safety, efficacy, and appropriate dosage.
2. Regulatory Trends: Despite the withdrawal of guidance, regulatory agencies globally are emphasizing the importance of diverse representation in clinical trials. For example, the European Medicines Agency (EMA) has issued similar calls for inclusivity.
3. Market Access: Sponsors and companies that fail to demonstrate diversity risk facing scrutiny during the approval process and encountering resistance in post-market settings.
4. Ethical Responsibility: Diverse trials help ensure that no patient population is left behind in the development of life-saving therapies. This is particularly crucial for conditions disproportionately affecting underrepresented groups.

While the ultimate goal of a research is to usher safe and effective treatments into market, those that deprioritize diversity in their studies risk their treatments resulting in adverse events, unintended harm, and market recalls. Prioritizing diversity in trial studies leads to more effective treatments and more successful therapies making it to market, ultimately derisking major negative effects for biotechnology organizations.

Challenges in Achieving Diversity in Clinical Trials

Despite its importance, achieving diversity in clinical trials is no small feat. Sponsors, CROs, and investigators often face significant hurdles, including:

1. Recruitment Barriers: Language, mistrust of medical research, logistical challenges, and lack of awareness can deter underrepresented populations from participating in trials.
2. Systemic Inequities: Healthcare access disparities make it difficult for some populations to even qualify for trials.
3. Complex Protocols: Stringent inclusion and exclusion criteria can inadvertently exclude diverse participants.
4. Cost: Reaching and engaging underrepresented populations often requires additional resources for community outreach, transportation, and other accommodations.

Turning Challenges into Opportunities for Diversity in Clinical Trials

Despite these challenges, there are actionable strategies that stakeholders can employ to promote diversity:

1. Community Engagement: Building relationships with community leaders, advocacy groups, and local healthcare providers can help bridge trust gaps and increase awareness.
2. Decentralized Clinical Trials (DCTs): By leveraging technology, such as telemedicine and home health visits, sponsors can reduce geographic and logistical barriers to participation.
3. Cultural Competence Training: Ensuring that clinical trial staff understand and respect cultural differences fosters trust and improves communication.
4. Adaptive Trial Designs: Utilizing flexible protocols that accommodate a broader range of participants can enhance inclusivity.
5. Data-Driven Recruitment: Using real-world data to identify and target underrepresented populations improves efficiency and impact.

The FDORA and What It Still Means for Diversity in Clinical Trials

The FDORA act reinforced the need for diversity by emphasizing its role in clinical trial design and execution. Even without explicit Diversity Action Plan guidance, the principles laid out in FDORA should remain a touchstone for sponsors and investigators.

FDORA encourages stakeholders to:

• Define Clear Goals: Set specific, measurable objectives for diverse representation.
• Report Outcomes: Share data on participant demographics and highlight successes and areas for improvement.
• Collaborate: Work with regulators, advocacy groups, and patients to develop best practices.

The Changing Political Landscape

The FDA’s decision to remove its Diversity Action Plan guidance cannot be viewed in isolation. It reflects a broader trend in the United States, where DEI initiatives are being scrutinized or rolled back in some sectors. This shift underscores the importance of grassroots and industry-led efforts to champion diversity in the absence of explicit regulatory mandates.

For clinical trials, this means sponsors, CROs, and investigators must take the lead in ensuring that diversity remains a priority. While political and regulatory landscapes may change, the core mission of clinical research—to improve patient health—demands that we continue to push for inclusivity.

Looking Ahead: A Call to Action

The removal of the FDA’s Diversity Action Plan guidance is not a signal to deprioritize diversity; rather, it’s a call to double down on our efforts. As an industry, we have a responsibility to ensure that the therapies we develop are safe and effective for everyone—not just a select few.

Achieving this vision requires a proactive approach, one that goes beyond checking regulatory boxes. It demands a commitment to embedding diversity into every stage of the clinical trial process, from protocol design to patient recruitment and beyond.

By broadening our definition of diversity and addressing systemic barriers to participation, we can create clinical trials that truly reflect the populations we aim to serve. The FDA may have shifted its guidance, but the purpose of diversity action plans—to ensure equitable, effective, and ethical clinical research—remains as strong as ever.

Conclusion

In a world where the political tides are shifting, the clinical trials industry has an opportunity to stand firm in its commitment to diversity in order to be successful. By embracing the principles of inclusivity laid out in the FDORA and continuing to champion the purpose behind the FDA’s original guidance, we can ensure that our research is not only socially responsible, but more scientifically sound and safe. The path forward is clear: diversity is not just a regulatory requirement; it is a necessity.

Leapcure is committed to diverse clinical trials, through EQuitable Clinical Trials. If you would like to learn more about clinical research, Leapcure, or the future of biotechnology, visit us at www.leapcure.com