Race and trial region changes in cancer clinical trials between 2013 and 2024

Abstract

Background The latest changes in racial and geographical enrollment in cancer clinical trials in the 2020s have not been fully characterized, despite ongoing measures by the US Food and Drug Administration (FDA) to enhance diversity. We aimed to quantitatively elucidate the trial population of FDA-approved cancer drugs by race and trial region in 2013–2024. Methods FDA drug approvals granted from January 2013 through December 2024 were reviewed by the FDA Oncology (Cancer)/Hematologic Malignancies Approval Notifications and FDA Application Review Files. Of 515 approval notifications screened, 92 eligible ones were analyzed. The primary endpoint was the ratio of each race and trial region among the datasets submitted for FDA approval. Results Our analysis included 23,539 participants. Although the majority race has remained White, the proportion of White decreased from 83.2% in 2013–2016 to 68.9% in 2021–2024. The proportion of Asians and Asian trial region increased from 9.3% and 7.4% in 2013–2016 to 21.4% (95% CI, 20.53–22.35) and 19.7% (95% CI, 18.81–20.57) in 2021–2024, respectively. The proportion of Black people remained under 4%. Conclusion From 2013 to 2016 to 2021–2024, Black people underrepresentation has persisted, whereas the enrollment of Asians at race level and participants from Asia at region level have increased.