As the White House kicked off a public forum on clinical trials on Wednesday, the FDA simultaneously published a delayed draft guidance on ensuring clinical trials become diverse.
The draft guidance outlines how biopharma companies can meet a new requirement to submit diversity action plans to increase enrollment of historically underrepresented populations.
The plans, which were created by the passage of the Food and Drug Omnibus Reform Act in 2022, must include the sponsor’s goals for enrollment, disaggregated by race, ethnicity, sex, and age of clinically relevant study populations; a rationale for such goals; and an explanation of how the sponsor intends to meet such goals.
Diversity in clinical trials has long been a goal of the FDA and the Biden administration. Treatments can affect different groups in different ways, and companies have historically dragged their feet on seeking out diverse populations to enroll in their trials. The NIH famously slowed down Moderna’s Covid-19 clinical trial to ensure a more diverse population was tested with the vaccine, and Biogen was criticized for enrolling fewer than 1% of Black or African-American participants in a trial for its Alzheimer’s drug, Aduhelm.
The FDA’s 23-page draft, which was released about six months later than when the law mandated it to be published, details how clinical study diversity “helps ensure that clinical studies appropriately test the product in a representative sample of the product’s intended use population.”
The draft guidance also explains the specific set of trials that will require these action plans, which are mostly for later-stage trials, but FDA also “strongly recommends that sponsors develop and implement a comprehensive diversity strategy across the entire clinical development program, including in early studies, when possible.”