Diversity Data In The US: Understanding The FDA's Push For More Representation In Clinical Trials

By Miranda McLaren

Diversity in clinical trials has been a topic of growing concern for years, but new FDA guidance for 2025 and beyond is driving the industry toward meaningful action.

Underrepresentation among clinical trial participants hampers the ability to fully evaluate the safety and efficacy of novel therapeutics, leading to limited evidence that may not generalize across diverse populations. This lack of inclusivity can have serious consequences, as seen in 2019 when the FDA excluded cisgender women from an approved HIV intervention due to the sponsor’s failure to investigate its effects in females.

Data from GlobalData’s Clinical Trials database highlights the scope of the issue: while 18.7% of participants in US-based studies between 2017 and 2024 identified as Black/African American, representation was far lower for Native American (0.7%), Native Hawaiian/Pacific Islander (0.3%), and Asian (4.8%) populations. Moreover, these figures may underestimate the problem, as only 38% of North American trials report participants' racial data. Addressing this disparity is crucial to ensuring equitable access to medical interventions and improving the quality of clinical research outcomes.