Clinical Trials Leading to Oral Chemotherapy Approvals Lack Black Participants

A study found that Black Americans are underrepresented in clinical trials supporting approval of oral chemotherapy drugs from the U.S. Food and Drug Administration. This study was published in JCO Oncology Practice.

The authors wrote, “Over the past 10 years, oral chemotherapy made up about half (45.6%) of all U.S. FDA–approved oncolytic and hematologic medications. Given the disparity in incidence and mortality rate because of certain cancers among Black Americans in the United States, a review of Black Americans’ representation in the clinical trials that lead to the development and FDA approval of oral chemotherapy drugs becomes imperative.”

The investigators retrospectively assessed the reporting of race in clinical trials leading to approval of oral chemotherapies between 2009 and 2019. They also evaluated the rate of inclusion of Black patients in these trials. The FDA’s Hematology/Oncology Approvals & Safety Notifications website and the clinical trials registry were queried to identify studies.

In total, 142 clinical trials met inclusion criteria, leading to the approval of 81 oral chemotherapy agents. Around half of these trials (74 trials; 52%) reported at least one race among participants and were included in the analysis. These trials comprised 35,933 patients. White patients made up 71.5% of participants. Around 17% of patients were Asian (n = 6,061), 2.5% were Black (n = 826), and 2.3% were Hispanic (n = 2.3%).

In conclusion, the authors wrote, “Black Americans were under-represented in clinical trials leading to FDA approval of oral chemotherapy drugs. There should be more Black Americans in cancer clinical trials to increase the generalizability of the results, improve outcomes, and eventually close the health disparity gap among this patient population.”