Examining the Representation of Minority Race and Ethnicity Groups in Breast Cancer Clinical Trials in the USA Published 2012–2022
摘要
Diversity of study populations in clinical trials is essential to addressing health outcome disparities in cancer care. The objective of this study was to examine the inclusion of minority race/ethnicity groups in breast cancer clinical trials published in the United States of America (USA) 2012–2022.
Patients and MethodsBreast cancer clinical trials published as a full manuscript in the USA 2012–2022 were identified. Trial characteristics and race/ethnicity of subjects were collected to assess the degree of reporting and inclusion of minority populations. Participation to Prevalence Ratios (PPRs) were utilized as a measure of inclusion.
ResultsIn 1068 trials (n = 871,683 subjects), race/ethnicity was reported in 785 (73.5%), increasing from 2012 to 2016 (68.8%) to 2017 to 2022 (79.3%, p < 0.001). Higher rates of race/ethnicity reporting were independently associated with later publication year, randomized or phase II trials, and those reporting social determinants of health. Of the 732,969 subjects for whom race/ethnicity was reported, 16,551 (2.3%) were Asian American/Pacific Islander (Asian), 43,288 (5.9%) were Black/African American, 22,464 (3.1%) were Hispanic/Latinx, and 570,897 (77.9%) were Non-Hispanic White. A PPR above 0.8 was achieved in 27.3% of trials that reported race for Asian subjects, 44.7% for Black/African American subjects, 27.4% for Hispanic/Latinx subjects, and in 5.7% for all three minority groups. All four primary race groups in the USA were represented in 24.7% of trials, and race/ethnicity was included as a factor in outcome analysis in 8.7%.
ConclusionsAlthough race/ethnicity reporting has improved, minority populations remain gravely underrepresented in breast cancer clinical trials, limiting the generalizability of trial results in these populations.