07/11/2024
Photo by Clay Banks on Unsplash
On June 26, 2024, the US Food and Drug Administration (FDA) released a new draft guidance “Diversity Action Plan to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies.” The underrepresented populations in clinical trials can be disaggregated by sex, age, and racial and ethnic demographics. If a subset of a population is not present during the clinical studies, potential differences in safety information may not be fully understood. In other words, the more representation from underrepresented populations, the greater the generalizability of the trial results that in turn broadens the intended patient population. This issue was addressed in an amendment to the Federal Food, Drug, and Cosmetic Act (FD&C Act) made by the Food and Drug Omnibus Reform of 2022 (FDORA) section 3601 of FDORA requires sponsors conducting clinical studies involving drugs, biological products, and devices to submit a Diversity Action Plan. A Diversity Action Plan has three required components:
The sponsor’s goals for enrollment: broken down into the categories of race, ethnicity, sex, and age group, a sponsor’s enrollment goals should reflect the distribution of a disease or condition throughout a population. If a specific disease or condition being treated for example was to predominately affect females compared to males then it would make sense for the enrollment goals to have more female participants. If a medical product is intended for the general population (ex. Vaccines) then the enrollment goals should be reflective of the national population.
The sponsor’s rationale for such goals: the rationale should include relevant background information about the disease or condition being treated that supports the enrollment goals.
An explanation of how the sponsor intends to meet the goals: there are a number of ways that a sponsor may go about meeting their enrollment goals that include, but are not limited to:
Engaging with communities: this can be done through routine interactions with community health workers, organizations, and advisory boards as well as patient advocacy groups, and local healthcare providers.
Providing cultural competency and proficiency training: this will help clinical investigators and research staff to engage with participants from different backgrounds in a professional and courteous manner.
Improving access to clinical studies: this can be achieved by limiting exclusion criteria, selecting sites that would facilitate enrollment of the representative populations, and considering the accessibility need of persons with disabilities.
The draft guidance is intended to help sponsors format their Diversity Action Plans and inform them about what should be considered in the content of the plan as well as the procedures for submitting plans and receiving feedback. The full draft guidance can be found here on the FDA website as well as the announcement of its release. The draft guidance is open to comments until September 26, 2024. Those who wish to comment may do so here. For more information on the diversity of clinical trial populations, Clinical Pathways has covered in previous blogs the release of the draft and final guidance for industry “Enhancing the Diversity of Clinical Trial Populations - Eligibility Criteria, Enrollment Practices, and Trial Designs.” Both of these entries can be found on the Clinical Pathways website here:
Comment Now! Enhancing the Diversity of Clinical Trial Populations (Draft Guidance)
New FDA Guidance! Enhancing the Diversity of Clinical Trial Populations
-The Clinical Pathways Team
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