Disparities in gynecologic oncology clinical trial availability in the United States: A state-level analysis.

Abstract

e23128 Background: Disparities in minority participation in gynecologic cancer clinical trials is well documented. FDA guidance stipulates geographic informed analyses to reduce barriers to trial participation. We performed a geographical analyses of gynecologic cancer clinical trials in the United States relative to racial distribution and social vulnerability indices to identify areas of increased need. Methods: We performed a cross-sectional analysis of NIH ClinicalTrials.gov by retrieving all trials first posted 1/1/2013 through to 1/10/2024. We searched for ovarian, uterine, cervical, endometrial, vaginal/vulvar and gynecological cancer. We reviewed enrollment criteria to exclude non-gynecological cancers (1643 trials) or non-invasive gynecological conditions (224 trials). We aggregated census data, state-level total population size, percent Non-Hispanic White (NHW), and the FEMA Expected Annual Loss per state as a measure of social vulnerability. Using R statistical software (v 4.3.1), we measured the association between these variables and the number of gynecological trials per 100,000 persons using Pearson’s correlation. Results: We identified 3,428 trials, filtered down to 1,561 invasive cancer trials. The most common trials were ovarian (911, 58.3%) and cervical (438, 28.0%), followed by endometrial (385, 24.6%), uterine (158, 10.1%), vulva-vaginal (78, 4.99%), and 7.62% genetic-based. Texas had the highest number of trials (501) followed by California (454) and New York (427). The state with the highest population-adjusted number of trials was South Dakota (8.57 trials per 100,000 persons), followed by Rhode Island at 8.38 per 100,000 persons. California, Mississippi, and Puerto Rico had the lowest number of trials per 100,000 persons with 1.148, 0.979, 0.466 respectively. States/territories with greater than 4 trials per 100,000 were comprised of populations that were > 50% NHW. The correlation between the state-level percentage of NHW in 2020 and the number of trials per 100,000 persons was p = 0.057 indicating that there was a correlation between Whiteness at the state-level and trial availability. We found that states with higher FEMA expected annual loss had lower numbers of gynecological trials per 100,000 persons (p < 0.001). Conclusions: We found a disparity in the geographical distribution of trials available for gynecological cancers that was correlated with racial disparities and social vulnerability. Efforts to increase decentralization of trials and improve access and availability of gynecologic cancer clinical trials are necessary to increase equity for minority representation in clinical trials at the national level.