JAMA Netw Open. 2024 Nov 4;7(11):e2447635. doi: 10.1001/jamanetworkopen.2024.47635.
ABSTRACT
IMPORTANCE: Disparities in minoritized racial and ethnic populations’ participation in gynecologic cancer clinical trials are well documented despite the high rates of endometrial cancer in these populations. Geographic proximity to trials is a critical component to ensure equitable trial access.
OBJECTIVE: To characterize the geographic distribution of gynecological cancer trials across the US and identify disparities.
DESIGN, SETTING, AND PARTICIPANTS: This study is a cross-sectional analysis of trials first posted on ClinicalTrials.gov from January 1, 2013, through January 10, 2024. This study involved a state-level analysis of clinical trials located in the US. Enrollment criteria of clinical trials for ovarian, uterine, cervical, endometrial, vaginal and/or vulvar, and other gynecological cancers were reviewed to exclude nongynecological cancers (1643 trials) or noninvasive gynecological conditions (224 trials).
EXPOSURE: The number of gynecological trials per 100 000 persons in each state.
MAIN OUTCOMES AND MEASURES: A state-level analysis was performed to determine whether gynecologic cancer clinical trial availability in the US is associated with other state-level characteristics to identify areas of increased need. Census data, state-level total population size, percentage of non-Hispanic White persons, and the Federal Emergency Management Agency expected annual loss per state as a measure of social vulnerability were aggregated. The association between these variables and the number of gynecological trials per 100 000 persons was measured using Spearman rank correlation.
RESULTS: Of the 1561 invasive gynecological cancer trials that met the inclusion criteria, most cancer trials were ovarian (911 trials [58.4%]), followed by cervical (438 trials [28.1%]), and endometrial (385 trials [24.7%]). Predominantly minoritized population-serving states (ie, those with <50% non-Hispanic White persons) had fewer than 4 trials per 100 000 persons, but this was not significant nationally (ρ = 0.20; 95% CI, -0.08 to 0.45; P = .16). States with higher Federal Emergency Management Agency expected annual loss had lower numbers of gynecological trials per 100 000 persons, which was significant nationally (ρ = -0.53; 95% CI, -0.70 to -0.29; P < .001).
CONCLUSIONS AND RELEVANCE: In this cross-sectional study of female gynecological cancer trials by state, states with particularly high economic vulnerability and minoritized populations had low clinical trial availability. Further efforts are needed to address disparities identified in this study to ensure equitable trial access.
PMID:39589740 | DOI:10.1001/jamanetworkopen.2024.47635
