Participation of African Americans in clinical trials supporting FDA approval of cancer drugs.

Abstract

e18135 Background: African Americans comprise 12% of the total United States population. Lifetime probability of developing cancer in African Americans is 37.55%. The 5-year relative survival rate is 68% in Caucasians and 61% in African Americans for all cancers combined. Concerns exist that African Americans are underrepresented in trials of cancer medications. We sought to examine African Americans participation for pivotal 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 75 drug approvals from 2014 to 2018. 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 61763 patients enrolled in clinical trials, which resulted in subsequent FDA approval. The proportion of African Americans enrolled in the clinical trials that led to cancer medication approval in the 5-year period was 7.44%. The calculated PPR for participation of African Americans in clinical trials that led to drug approval for all cancers combined was 0.31. The results were consistent across major cancer subtypes including breast cancer (PPR of 0.29), prostate cancer (PPR of 0.18), and lung cancer (PPR of 0.15). Skin cancer, colorectal cancers and hematological malignancies results were also consistent with low PPR. Conclusions: African Americans were under represented in trials of drugs for all cancer types combined. Efforts should be made to increase the proportion of participation of African Americans in clinical trials.