The US Food and Drug Administration (FDA) has released new draft guidance to enhance racial, ethnic, and other forms of diversity in clinical trials conducted by drugmakers and medical device manufacturers. The recommendations offer a structured approach for companies and researchers to set and achieve enrolment goals segmented by age, ethnicity, sex, and race.
The initiative seeks to address the longstanding issue of underrepresentation in clinical trials, particularly among Black Americans and other groups who face higher rates of certain diseases but participate less frequently in studies. By improving the demographic composition of trial participants, the FDA hopes to ensure that research findings are more representative of the general population.
According to the FDA, the “diversity action plans” should be designed with the estimated prevalence of the disease being studied in mind. Richard Pazdur, director of the FDA’s Oncology Center of Excellence, emphasised the importance of these plans, saying that they may help ensure that sponsors think critically and intentionally about the many characteristics of the patient population they aim to treat when designing their clinical study.
Companies required to submit diversity plans
Although the guidance is not legally binding, companies seeking FDA approval for their products typically adhere to it. Under the 2022 Food and Drug Omnibus Reform Act, the FDA will now require companies to submit plans detailing how they intend to increase diversity in studies for most new drugs and medical devices.
The agency also outlined the criteria and process for evaluating manufacturers’ requests to be exempt from declaring their diversity goals. To help achieve these enrolment objectives, the FDA suggests improving access to clinical trials by initiating studies in geographically diverse locations.
The draft guidance will be open for public comment for 90 days before finalisation. All studies that begin enrolment within six months after the final guidelines are published must comply with the new standards.