This FDA Guidance Wants to Get More Black Americans into Clinical Trials

The FDA has released the latest draft outlining new requirements for how pharmaceutical and medical device companies should consider race and ethnicity when designing clinical trials. The new requirement is mandated by a recent law, the Food and Drug Omnibus Reform Act, better known as the FDORA Act. In the past, many clinical trials haven’t included enough people from different racial and ethnic backgrounds, primarily focusing on white men. This can be a problem because many medications and devices may affect people of varying races differently. The FDA emphasizes that including more diverse participants not only benefits these groups but also improves the overall understanding of the disease or treatment being studied. New FDA clinical trial requirements The FDA’s draft guidance asks companies to develop “Diversity Action Plans.” These plans will need to explain: How many people from different racial and ethnic groups the company aims to recruit for their trials, considering factors like age and sex. Why they chose these goals and how they plan to reach them. The FDA also suggests ways companies can increase diversity in their trials, such as: Partnering with community groups Making trials more accessible (e.g., providing transportation) Choosing trial sites in diverse areas...