The following Insight is a featured article from WCG’s 2025 Trends & Insights Report. If you would like to read more insights from this report, please click here.
Diversity in clinical trials isn’t about fulfilling a mandate or aligning with a social agenda—it’s about ensuring good science and better patient outcomes. With the FDA’s diversity action plan requirements for Phase III clinical trials set to take effect in mid-2025, there is no better time to prioritize inclusive trial designs across all phases of drug development.
Scientific evidence underscores the critical importance of diversity. Differences in medical product safety and effectiveness can emerge based on factors such as age, ethnicity, sex, and race. Without adequately representing the populations most affected by a disease, clinical trial data risks being biased, potentially resulting in treatments that are less effective—or even harmful—for underrepresented groups. Including diverse participants early in the research process produces more robust efficacy and safety data, paving the way for advancements in precision medicine.
Looking ahead, this scientific rigor demands a proactive approach. To improve the generalizability of trial results, researchers must align trial demographics with the real-world populations affected by the disease under study. By doing so, clinical research can better inform public health strategies and reduce disparities in both treatment access and outcomes.
Historical data shows underrepresentation of minority groups in clinical trials, with Black and Hispanic populations frequently accounting for less than 10% of participants, despite their higher disease burdens for conditions like diabetes and certain cancers. Addressing this disparity is crucial for ensuring trial outcomes are applicable to the populations most affected by these diseases.
Moreover, fostering diversity in trials offers an opportunity to rebuild public trust. Medical research has a complicated history with marginalized communities, often perpetuating bias or exclusion. Intentional engagement and relationship-building within these communities are essential to restoring confidence in the clinical trial process and demonstrating that medical progress truly serves everyone.
The FDA’s upcoming diversity requirements provide a baseline, but science calls us to go further. By examining broader biological and social determinants of health, researchers can create trials that contribute not just to innovation but also to equity in healthcare. In 2025, the focus on inclusive trial design will not only meet regulatory expectations but will also help ensure that medical breakthroughs have a global and equitable impact.
Related Insights:
FDA’s Path Toward Diversity in Clinical Trials: The DEPICT Act and Sponsor Responsibility
Whitepapers
The DEI Mandate: What’s on the Horizon and What’s Needed for IRB and Recruitment Processes (Part 1 of 2)
Videos
The DEI Mandate: How to Accelerate Diversity Initiatives with Data Analytics and Planning (Part 2 of 2)
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