Diversity in Clinical Trials: The Path Forward Amid Uncertainty

Ensuring diversity in clinical trials is more than a regulatory requirement—it is essential for developing safe and effective therapies that benefit all patients. Historically, clinical research has failed to adequately represent racial and ethnic minorities, older adults, and other underrepresented groups, leading to knowledge gaps in drug efficacy and safety across different populations.

The consequences of inadequate diversity in clinical trials extend beyond theoretical concerns. Beyond the scientific implications, a lack of diversity can lead to inequitable healthcare. Minority populations often face higher disease burdens yet remain underrepresented in studies evaluating treatments for those very conditions. This issue is especially problematic in areas like cardiovascular disease, oncology, and immunology, where biological and genetic factors heavily influence drug response.

For instance, ACE inhibitors, commonly prescribed for hypertension, are significantly less effective in African American patients, who tend to have a lower renin profile, making alternative treatments like calcium channel blockers or diuretics more suitable. Similarly, warfarin, a widely used blood thinner, requires different dosing in Asian patients due to genetic variations in drug metabolism, putting them at higher risk of bleeding complications if dosed incorrectly. These examples underscore the importance of diverse representation—without it, certain populations may receive suboptimal treatments, leading to preventable adverse effects and disparities in healthcare.

Enhancing Diversity in Clinical Trials: Beyond Enrollment Targets

Recognizing the importance of diversity in clinical research, the FDA has implemented new regulations requiring sponsors of Phase III and pivotal studies to submit Diversity Action Plans (DAPs). These requirements were established under the Food and Drug Omnibus Reform Act (FDORA) of 2022. The plans outline recruitment goals and strategies to ensure that study populations reflect real-world demographics.

A well-designed Diversity Action Plan (DAP) should go beyond simply setting enrollment targets. It must incorporate practical, evidence-based strategies to ensure meaningful inclusion of underrepresented populations. Key approaches include:

• Expanding Trial Sites – Including community-based clinics alongside large academic hospitals to improve accessibility for diverse populations.
• Building Local Partnerships – Collaborating with trusted local organizations, minority physician networks, and patient advocacy groups to enhance credibility and encourage participation.
• Leveraging Decentralized Trial Options – Utilizing telemedicine visits and at-home drug delivery to reduce logistical barriers that often deter participation.

By implementing these strategies, sponsors can foster more inclusive clinical trials that better represent the broader patient population.

Regulatory Measures and Uncertainty

However, the regulatory landscape has become uncertain. In January 2025, the FDA removed previously issued draft guidance on clinical trial diversity from its website, following an executive order affecting diversity, equity, and inclusion policies across federal agencies. While the reasoning behind this decision remains unclear, it has led to confusion among sponsors about the long-term expectations for trial diversity.

At the same time, Robert F. Kennedy Jr., the nominee for Secretary of Health and Human Services, has publicly stated that he intends to finalize new diversity regulations. However, without clear policy direction, many in the industry are left wondering whether trial sponsors should continue prioritizing diversity at the same level—or if these initiatives will become less of a regulatory focus in the coming years.

Successful Initiatives to Improve Diversity

Despite ongoing challenges, many organizations are actively enhancing diversity in clinical trials. Through expanded research sites, community engagement, and partnerships with underrepresented groups, they are making meaningful progress. Here are some key initiatives:

• Bristol Myers Squibb expands clinical trial diversity by establishing research sites in diverse communities, investing in workforce representation, fostering community trust, and addressing social barriers to participation.
• Sanofi collaborates with underrepresented communities to design inclusive clinical trials, aiming to ensure study populations reflect real-world demographics.
• Abbott through its Diversity in Clinical Trials initiative has achieved 54% female and 44% Hispanic/non-white participation in US clinical trials, closely mirroring national demographics.

These strategies demonstrate how targeted efforts can enhance diversity in clinical trials, even amid regulatory uncertainty.

The Future of Inclusive Research

Regardless of shifting regulations, the need for diversity in clinical trials remains undeniable. The scientific community must take a proactive approach, not just to comply with potential future mandates but to ensure that all patients, regardless of race, ethnicity, age, or gender, have access to safe, effective treatments that are truly designed for them.

Even in the absence of immediate regulatory requirements, sponsors should continue integrating real-world diversity considerations into trial design, from recruitment strategies to data analysis. A one-size-fits-all approach to medicine is no longer acceptable—and the clinical trials of today must reflect the patient populations they aim to serve tomorrow.

At Cromos Pharma, we recognize that diversity in clinical research is not just a regulatory requirement but a scientific and ethical imperative. Our team is committed to designing and executing clinical trials that prioritize inclusivity, ensuring that investigational treatments benefit the broadest possible patient populations.

As sponsors and researchers, how is your organization addressing diversity in clinical trials, especially considering recent regulatory uncertainty? Let’s discuss how we can drive meaningful change and build a more inclusive future for clinical research.