Leveling the playing field: Identifying barriers and patterns of endometrial cancer clinical trial enrollment for underrepresented groups (013)

Abstract

<b>Objectives:</b> Non-White women with endometrial cancer have worse outcomes than White women, even when controlling for tumor factors. Clinical trial enrollment may mitigate disparities by providing access to novel therapies and guideline-concordant care. Disparities in clinical trial enrollment by race have been described, and the race was only reported in Gynecologic Oncology Group trials beginning in 1994. We aimed to determine clinical trial eligibility criteria that would adversely impact enrollment of underrepresented groups and assess the diversity in clinical trials for which demographic information was published. <b>Methods:</b> We searched Clinicaltrials.gov for endometrial cancer studies in the United States conducted between 1998 and 2021. Studies of all stages from currently recruiting to published studies were included. Studies were excluded if they included other sites of disease. The inclusion and exclusion criteria of each study were reviewed to determine if demographic factors were used as screening criteria. For published studies, we identified demographic variables that were included in the study. Our outcome of interest was the enrollment of minorities in clinical trials and the characterization of inclusion/exclusion factors that would adversely impact enrollment of groups historically underrepresented in trials. Data were compared using Chi-square tests and descriptive analysis. <b>Results:</b> A total of 260 endometrial cancer trials were included in the study. Of these, 27 (10%) studies specified language in inclusion/exclusion criterion, 23 (9%) trials excluded all non-English speakers, however, four (2%) studies included Spanish speakers. Observational studies were more likely to exclude non-English speakers than clinical trials (8/36, 22% vs 19/224, 8%, p=0.019). University-sponsored studies were more likely to have language exclusions than industry-sponsored trials (25/140, 18%, vs 0/31, 0%, p<0.001). Of 105 studies with published results, 98 (93%) reported age, 61 (58%) reported race, 23 (22%) reported ethnicity, 7 (7%) reported education, 6 (6%) reported income, and 3 (%) reported marital status. No studies reported insurance, language, or religion. Of studies with race and ethnicity information available, we observed that 80% of the pooled cohort was White, 10% Black or African-American, 4% Hispanic, and 4% Asian. Native-American, Hawaiian, mixed-race all constituted <1% of the cohort. <b>Conclusions:</b> Over the last three decades, one in ten studies in gynecologic oncology did not allow non-English speakers to enroll in clinical trials. Allowing access to clinical trials regardless of primary language may decrease barriers to enrollment for women historically underrepresented in trials. Though there is increased awareness of the importance of diversifying clinical trial enrollment, demographic information remains omitted in many studies. Improving demographic data reporting is imperative and can identify additional barriers to trial enrollment.