A cross-sectional study published in JAMA Network Open reveals significant geographic disparities in the availability of gynecologic oncology clinical trials across the United States, particularly impacting economically vulnerable and minoritized populations. The study, which analyzed 1,561 trials from ClinicalTrials.gov, highlights that states with higher Federal Emergency Management Agency (FEMA) expected annual loss (EAL) have significantly lower numbers of gynecological trials per 100,000 persons (ρ = -0.53; 95% CI, -0.70 to -0.29; P < .001). This suggests a correlation between economic vulnerability and reduced access to potentially life-saving clinical research opportunities.
Trial Availability and Racial Disparities
The research also found that states predominantly serving minoritized populations (i.e., those with <50% non-Hispanic White persons) tend to have fewer than 4 gynecological trials per 100,000 persons. While this association was not statistically significant nationally (ρ = 0.20; 95% CI, -0.08 to 0.45; P = .16), the data indicates a trend where states with larger minoritized populations have diminished access to gynecologic cancer trials. This disparity is particularly concerning given that gynecological cancers disproportionately affect patients from marginalized racial and ethnic communities, with higher mortality rates observed among Black individuals for cervical, endometrial, and ovarian cancers.
Types of Gynecologic Cancers Investigated
The majority of the 1,561 clinical trials identified focused on ovarian cancer (58.4%), followed by cervical (28.1%), and endometrial (24.7%) cancers. The study also noted that 7.6% of trials were explicitly studying a genetic factor, and 42.2% were broad, including many cancer types, indicative of basket trials. These basket trials test how a drug performs across a wide variety of cancer types that all share a common genetic biomarker.
Geographic Distribution of Trials
Texas had the highest number of trials (501), followed by California (454) and New York (427). However, when adjusted for population size, South Dakota (8.60 trials per 100,000 persons) and Rhode Island (8.40 trials per 100,000 persons) had the highest rates, while California (1.10), Mississippi (0.98), and Puerto Rico (0.47) had the lowest. Interestingly, there was little association between the number of gynecological trials per capita and the age-adjusted rates of gynecological cancers among female non-Hispanic White persons.
Addressing the Disparities
The study underscores the urgent need for targeted interventions to address these geographic disparities. "Efforts are needed to address disparities identified in this study, especially the low clinical trial availability in states with particularly high economic vulnerability and minoritized populations," the authors stated. Potential solutions include increasing practitioner availability in underserved areas, addressing referral patterns, and ensuring that clinical trials are accessible to diverse populations.
Limitations
The authors acknowledge that the study's focus on state-level data may overlook lower-level factors contributing to trial access. However, the state-level analysis was chosen due to the rarity of gynecological cancer trials and the availability of relevant data at this level. Despite these limitations, the study provides valuable insights into the geographic disparities in gynecologic cancer trial availability and highlights the need for further research and targeted interventions to ensure equitable access to clinical trials for all patients.
