Abstract PO-224: Disproportional representation of racial and ethnic minorities in colorectal cancer clinical trials

Abstract

Abstract Introduction: Despite overall decreasing rates of colorectal cancer, significant disparities in mortality disproportionately impact racial and ethnic minorities. Ancestral differences in tumor biology may affect how patients respond to cancer therapeutics, potentially impacting treatment efficacy. Underrepresentation in clinical trials may perpetuate disparities in colorectal cancer in racial and ethnic minorities. We aim to determine the representation of racial and ethnic minority patients in colorectal cancer clinical trials and to explore how reporting and representation has changed over time. Methods: A database analysis was performed of ClinicalTrials.gov from 2008-2021 of all colorectal, colon and rectal cancers. Trials were excluded if results were not reported, studies were performed outside the US or in other cancer types. Representation was determined using an enrollment fraction (EF), the proportion of trial participants adjusted for prevalence of colorectal cancer for each racial and ethnic subgroup. Wilcoxon rank sum and Kruskal-Wallis tests were used to determine whether the distribution of EF ratios among subgroup trials differed from 1. Results: 255 colorectal cancer clinical trials were analyzed, including 253,135 participants. Overall, gender was reported 98.8% of the time, whereas race was reported in 44.7% of trials and ethnicity was reported in 29.4% of trials. Though data reporting on race and ethnicity have improved over time, rates of reporting remain poor in 2021 (race 68.2%, ethnicity 45.5%). Black (EF 0.7), Asian (EF 0.3), American Indian and Alaskan Native (EF 0.0) and Hispanic (EF 0.4) patients remain underrepresented when compared to US rates of colorectal cancer (p<0.0001). Conclusions: Non-White and Hispanic patients with colorectal cancer are underrepresented in colorectal cancer clinical trials. Though reporting of patient race and ethnicity continue to increase, there are opportunities for further improvement. Equitable representation of racial and ethnic minorities in colorectal cancer clinical trials facilitates the understanding of biologic responses to cancer therapeutics and has the potential to improve cancer health disparities. Citation Format: Kelly M. Herremans, Andrea N. Riner, Katherine Y. Tossas, Shreya Raman, Stephen P. Sharp, Jose G. Trevino. Disproportional representation of racial and ethnic minorities in colorectal cancer clinical trials [abstract]. In: Proceedings of the AACR Virtual Conference: 14th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2021 Oct 6-8. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2022;31(1 Suppl):Abstract nr PO-224.