The following is a summary of “Demographic reporting and language exclusion in gynecologic oncology clinical trials,” published in the January 2024 issue of Obstetrics and Gynecology by Lee, et al.
For a study, researchers sought to investigate the impact of clinical trial eligibility criteria on the enrollment of underrepresented groups and evaluate the representation of demographic information in published gynecologic oncology research.
A comprehensive search of ClinicalTrials.gov was conducted to identify gynecologic oncology studies from 1997 to 2021. Each study’s inclusion and exclusion criteria were scrutinized to ascertain the utilization of demographic factors in enrollment screening. Additionally, demographic variables were identified in published studies. The anticipated enrollment in clinical trials based on disease incidence and mortality was juxtaposed with the actual enrollment concerning racial demographics.
A total of 1,597 gynecologic oncology studies were analyzed, with ovarian cancer studies comprising 55% (883), cervical cancer studies 21% (336), uterine cancer studies 17% (262), and multisite gynecologic oncology studies 7% (116). Among the 581 published studies, 95% (554) reported age, 63% (363) reported race, and 29% (171) reported ethnicity. Cervical cancer studies exhibited the highest propensity to disclose demographic information, notably race (P=.026) and ethnicity (P<.001). Throughout the study duration, 12% (189) of trials excluded participants based on language barriers. Industry-sponsored trials (OR: 0.07, 95% CI: 0.02–0.30) and organization-sponsored trials (OR: 0.40, 95% CI: 0.22–0.73) were less prone to language-based exclusions than investigator-initiated trials. Notably, White patients constituted a minority (37%) in cervical cancer trials, in contrast to 85% in uterine cancer trials and 82% in ovarian cancer trials.
Over the past three decades, approximately 10% of gynecologic oncology trials have imposed language-based exclusion criteria. While race and ethnicity were reported in more than half of the studies, there was an urgent call for initiatives to enhance transparency in recruiting underrepresented patient populations and reporting demographic data.