The U.S. Food and Drug Administration on Wednesday issued guidance to drugmakers and medical device makers on steps to improve racial, ethnic, and other diversity in their clinical trials.

The draft guidance outlined steps for companies and researchers conducting trials to submit goals for study enrollment, categorized by age group, ethnicity, sex, and race, and describe how they intended to meet those goals. This approach was part of the U.S. Food and Drug Administration (FDA)'s Diversity Action Plans (DAPs), which aimed to increase the participation of underrepresented populations in clinical studies.

The FDA also detailed the criteria for obtaining a waiver from declaring these goals, indicating situations where such goals might be impractical or unnecessary. These DAPs had to specify enrollment goals, the rationale behind these goals, and the measures that would be taken to achieve them. The guidance included a waiver provision for instances where meeting these diversity goals might not be feasible.

Historically, clinical trials had seen low participation rates from underrepresented groups, including Black Americans, who often had higher rates of certain diseases than the general population. This lack of representation could impact the applicability of clinical trial results across diverse populations.

While the FDA's formal guidance was not legally binding, it was typically adhered to by companies seeking the agency's approval for their products. The guidance emphasized that the consistent implementation of actions to improve representativeness in clinical studies could support more equitable and timely access to medical innovations, enhance the generalizability of study results, and inform the safe and effective use of medical products for all patients.