Abstract P2-10-11: Participation of African Americans in clinical trials supporting FDA approval of breast cancer medications

Abstract

Abstract BACKGROUND African Americans comprise 12% of the total United States population. Lifetime probability of developing cancer in African Americans is 37.55%. Lifetime probability of developing breast cancer in African Americans is 11.1%. African Americans have higher lifetime probability of dying because of breast cancer compared to Caucasians (3.3% versus 2.7%). Concerns exist that African Americans are underrepresented in trials of breast cancer medications. We sought to examine African Americans participation for pivotal breast cancer medications trials submitted to the U.S. Food and Drug Administration (FDA) supporting marketing applications. METHODS On the basis of publicly available FDA reviews, the authors assessed enrollment of African Americans in trials supporting 9 drug approvals from 2014 to 2018. Those trials resulted in approval of medications to treat breast cancer. Prevalence-corrected estimates for the participation of African Americans were calculated as the percentage of African Americans among trial participants divided by the percentage of African Americans in the disease population (participation to prevalence ratio [PPR]), with a range between 0.8 and 1.2 reflecting similar representation of African Americans in the trial and disease population. RESULTS A total of 22,075 patients enrolled in clinical trials, which resulted in subsequent FDA approval. The proportion of African Americans enrolled in the clinical trials that led to breast cancer medication approval in the 5-year period was 6.83%. The calculated PPR for participation of African Americans in clinical trials that led to drug approval for breast cancer was 0.29. CONCLUSIONS African Americans were under represented in trials of drugs for breast cancer. Efforts should be made to increase the proportion of participation of African Americans in clinical trials. Citation Format: Samer Al Hadidi, Martha Mims, Courtney Miller-Chism, Rammurti Kamble. Participation of African Americans in clinical trials supporting FDA approval of breast cancer medications [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr P2-10-11.