The public and private sectors have an obligation to increase representation in clinical trials to reduce barriers to care and foster better health outcomes. Congress, federal public health agencies — including the FDA and NIH — and the biomedical industry must implement meaningful policies that make diverse enrollment in clinical trials a priority.
Ensuring that clinical trial participation reflects an increasingly diverse America is not only fundamental to public health, but imperative to health equity. Despite racial and ethnic minority groups comprising more than 40 percent of the U.S. population, clinical trials have historically underrepresented, and even excluded, these patient communities.
In 2021, nearly 74 percent of participants in trials for drugs approved by the FDA were white. When compared to the disproportionate impact of certain diseases on racial and ethnic minority groups, a persistent lack of representation in trials is disconcerting.
Limited diversity in clinical trials, which goes beyond racial and ethnic group representation, can result in skewed data that threatens real-world application of trial findings. This jeopardizes treatment efficacy and patient safety across underserved groups, which can exacerbate disparities in quality of care and care delivery.