Ethnic disparities in clinical trials for FDA-approved drugs in breast cancer: A post-COVID era analysis (2020-2024).

Abstract

e13759 Background: Despite advances in cancer treatment, racial and ethnic minorities remain significantly underrepresented in cancer research, particularly in clinical trials. This underrepresentation raises concerns about the transferability of findings to diverse patient populations as well as equitable treatment outcomes. This study evaluates racial representation in breast cancer clinical trials supporting FDA-approved treatments since 2020. Methods: We analyzed racial representation in breast cancer clinical trials by examining data from 9 industry-sponsored trials, encompassing 9,688 patients. Racial distribution data were obtained from these trials, and SEER incidence rates were used to determine expected participation proportions. A chi-square goodness-of-fit test was performed to examine disparities between observed and expected representation among White, Black, Asian, and Hispanic populations. P-values were calculated to assess the statistical significance of these differences. Results: Out of a total of 16 industry trials reviewed, 6 (37.5%) did not present any race data, 1 trial presented white vs non-white, and none presented data on Hispanic participants. Among the nine trials reporting race, White participants were overrepresented (70.7%, p < 0.0001), Black participants were significantly underrepresented (2.35%, p < 0.0001), and Asian participants were also overrepresented but to a lesser extent ( p < 0.0001). Some of the trials were international and domestic. Conclusions: Our findings highlight persistent racial disparities in breast cancer clinical trials, with significant underrepresentation of Black participants and a complete lack of Hispanic-specific data. Lack of diversity in clinical trials threatens the applicability of these treatments across different populations, as well as raises concerns about equitable access to the latest advancements in cancer care. Enhancing recruitment strategies, standardizing race and ethnicity reporting, and establishing policy-driven diversity targets are key steps toward ensuring clinical trials more accurately represent the populations they aim to serve.