Back to: FDA Regulatory Education for Industry (REdI) 2024 Conference – Plenary and Drugs Track
Presenter
Aden S. Asefa, MPH
Drug Trials Snapshot Lead
Office of Drug Evaluation Sciences (ODES)
Office of New Drugs (OND)
Center for Drug Evaluation and Research (CDER)
US Food and Drug Administration (FDA)
Aden Asefa started her FDA career as an ORISE Fellow with the Center for Food Safety and Applied Nutrition. From 2012-2014, she worked in Tobacco regulation in which she managed portfolio applications of Tobacco companies under the Family Smoking Prevention & tobacco Control Act. In 2015, Ms. Asefa switched gears again at the Agency and worked for Center for Devices and Radiological Health (CDRH) and managed Advisory Committee Public Meetings. Before starting her career in diversity in Clinical trials in 2022, she worked in the Office of Commissioner supporting Commissioner Dr. Califf in various FDA issues.
Abstract
Aden Asefa discusses the critical importance of increasing diversity in clinical studies to ensure drug development programs generate data reflective of the diverse US population, potentially identifying differences in safety and efficacy outcomes. Drawing on various statutory requirements and FDA guidance documents, the presentation focuses on the Drug Trial Snapshots program, implemented in 2015. This program serves as FDA’s effort to make demographic subgroup data more available and transparent for approved novel molecular entities and original biologics. Drug Trial Snapshots provide consumers and healthcare professionals with information about who participated in key clinical trials, including breakdowns by sex, race, age, and ethnicity, as well as trial locations. The most recent 2023 annual report details the demographic composition of participants in pivotal trials for approved therapies, including data on US versus global enrollment percentages, a recent addition. While the program reports the data seen in trials, understanding representation fully requires considering the prevalence of the disease in specific demographic groups. Identifying and addressing opportunities for improvement in enrolling diverse study populations remains an ongoing effort, acknowledging challenges such as location, health equity, trust, and recruitment strategies.