We Should Not Be Surprised: COVID-19 Disparities Lay Bare What’s Been There All Along

WCG Talks Trials

In this episode, former Assistant FDA Commissioner Jonca Bull, MD, discusses racial disparities in healthcare, how COVID-19 has made them impossible to ignore, and how this highlights the need for diversity in clinical trials.

Low-income minority communities are being hit disproportionately hard by COVID-19. Dr. Bull isn’t surprised: The current crisis has simply magnified existing disparities. A multitude of factors are at play, including lack of access to healthcare and healthful food. As a result of these and other issues, certain underlying health conditions are more prevalent in low-income minority communities.

Clinical trials must include these populations so we can truly understand COVID-19 and how to treat it in real-world conditions.

In fact, the FDA has long had guidance on how to make trials more diverse:

• Collection of Race and Ethnicity Data in Clinical Trials—Guidance for Industry and Food and Drug Administration Staff
• Enhancing the Diversity of Clinical Trial Populations—Eligibility Criteria, Enrollment Practices, and Trial Designs: Guidance for Industry

She emphasizes that African Americans are willing--sometimes more willing than others--to participate in clinical trials. But they must be invited, and trials must be designed with consideration of the obstacles they face because of where they live and how they work.

Dr. Bull serves as a consultant focused on drug development and regulatory considerations; she helps guide the strategic development and implementation of clinical trial protocols. She has served in various roles, including as assistant commissioner at FDA with a focus on diverse populations and clinical trials.