Promoting Clinical Trial Diversity: A Highlight of Select US FDA Initiatives.

ABSTRACT

Although the population in the United States is diverse, there are disparities in healthcare outcomes in some populations, for example, based on characteristics such as race, ethnicity, sex, gender, age, socioeconomic status, and geographic location. Despite disproportionate healthcare outcomes, certain populations are frequently under-represented in clinical trials intended to support applications requesting US Food and Drug Administration (FDA) approval to market a drug or biologic. Additionally, safety and efficacy of therapeutic products may vary based on intrinsic (e.g., sex, age, race, and ethnicity) and/or extrinsic (e.g., drug interactions and medical practice) factors. Enrolling diverse populations in clinical trials can aid in addressing disparities and better inform the use of medical products in all patients who will use them upon approval. Herein, we outline a few initiatives and activities, such as policy development, regulatory review, regulatory research, and stakeholder engagement, that the FDA has undertaken to promote diversity in clinical trials, to support submission of such information in marketing applications for subgroup analyses, and to communicate information to the public.