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

Abstract

e13816 Background: Equitable cancer treatment outcomes, as well as the generalizability of treatment application relies in part on diverse representation in the clinical trials that support the use of said treatments. However, in post covid-19 era, disparities in racial and ethnic participation continue to persist. This study evaluates the racial and ethnic composition of Industry sponsored Clinical Trials for Colon Cancer Treatments that became FDA approved post 2020, and compares to the expected distribution based on SEER incidence data. Methods: We analyzed racial demographics from five industry-sponsored colon cancer trials, from which only three (60%; NCT03785249, NCT05198934, and NCT04737187) included racial and ethnic data comprising 728 participants. The observed racial distribution was compared against SEER incidence data for colon and rectal cancer. Expected counts were derived by normalizing SEER incidence rates to the total trial enrollment. A chi-square test was performed to assess statistical significance. Results: Among trial participants, 79.4% were White, 4.6% Black, 10.4% Asian, 5.5% Hispanic, and 0.1% American Indian/Alaska Native (AI/AN). In contrast, SEER data suggests an expected distribution of 18.8% White, 22.1% Black, 15.0% Asian, 17.7% Hispanic, and 26.4% AI/AN. Chi-square analysis confirmed significant disparities across all racial groups (p < 0.001), with White participants overrepresented (χ² = 1748.64, p < 0.001), while Black (χ² = 126.30, p < 0.001), Asian (χ² = 11.75, p = 0.0006), Hispanic (χ² = 70.98, p < 0.001), and AI/AN individuals (χ² = 269.23, p < 0.001) were underrepresented. Some of the trials were international and domestic. Conclusions: Our findings underscore persistent racial and ethnic disparities in colon cancer clinical trials, with White participants overrepresented and Black, Hispanic, Asian, and AI/AN populations underrepresented. Additionally, two out of five trials failed to report any racial or ethnic data, reflecting a broader failure to prioritize diversity in clinical research. The lack of adequate representation threatens the generalizability of trial findings and equitable access to emerging therapies. Addressing these disparities requires urgent efforts to implement more inclusive recruitment strategies and standardized race/ethnicity reporting to ensure fair and effective treatment outcomes for all populations.