4 Perspectives on FDA’s Diversity Action Plan Guidance

In June, the FDA released its Diversity Action Plan guidance. The document outlines requirements for sponsors on submitting diversity plans to the agency. Sponsors of clinical trials must now provide their rationale and goals for patient enrollment—separated by key socioeconomic factors such as ethnicity, sex, and race—and how they intend to meet those goals.

In a press release from the time of when the guidance was announced, FDA Commissioner Robert M. Califf, MD, said, “The agency’s draft guidance is an important step—and one of many ongoing efforts—to address the participation of underrepresented populations in clinical trials to help improve the data we have about patients who will use the medical products if approved.”

Since the key announcement, Applied Clinical Trials has spoken with several industry leaders on how this guidance will impact sponsors. In this slideshow, Del Smith, PhD, co-founder & CEO of Acclinate; Pamela Tenaerts, MD, MBA, chief scientific officer, Medable; Luke Gelinas, PhD, senior chair director, Advarra; and Pam Diamond, MD, chief medical officer & co-founder, Curavit share their perspectives on one of FDA’s latest initiatives to increase diversity in clinical trials.

Image Credit: © Jakub Krechowicz - stock.adobe.com