There are disparities in gynecologic oncology clinical trial enrollment based on race and ethnicity, according to a recent study published in the American Journal of Obstetrics & Gynecology.
Takeaways
- The study reveals disparities in gynecologic oncology clinical trial enrollment based on race and ethnicity.
- Underrepresented racial and ethnic groups experience worsened outcomes in gynecologic malignancies compared to White patients. Survival rates for ovarian cancer increased among White patients but decreased among Black patients between 1990 and 2009.
- Black patients face a 2-fold increased rate of endometrial and cervical cancer mortality, highlighting significant health disparities.
- Survival rates are improved by participation in clinical trials, suggesting their crucial role in reducing disparities in outcomes. However, racial and ethnic minorities are often underrepresented in these trials.
- The analysis of gynecologic oncology studies from 1997 to 2021 indicates poor rates of enrollment among diverse racial and ethnic populations. The study suggests the need for priority alignment, changes in funding mechanisms, and collaboration among sponsors to address these disparities.
Outcomes of gynecologic malignancies are worsened among underrepresented racial and ethnic groups compared to White patients, with an increase of ovarian cancer survival observed among White patients between 1990 and 2009 but a decrease observed among Black patients. Black patients also face a 2-fold increased rate of endometrial and cervical cancer mortality.
Survival rates are improved by participation in clinical trials, and disparities in outcomes may be reduced. However, racial and ethnic minorities are often underrepresented in cancer clinical trials.
Investigators conducted a study to provide updated data on racial and ethnic enrollment in gynecologic oncology trials. Data was obtained from gynecologic oncology studies from 1997 to 2021, found using the National Institutes of Health trials registry.
Studies included cervical, uterine, and ovarian cancer studies, with vulvar and vaginal cancers categorized as cervical cancer. Studies with nongynecologic sites of disease were excluded from the analysis.
Observational and interventional studies were included. Observational studies were those where participants were not assigned to an intervention but were placed in a study group to evaluate health outcomes. Interventional studies were those where participants were assigned to receive an evaluated intervention.
Inclusion and exclusion criteria of studies were evaluated to identify potential barriers for underrepresented groups to enroll. Demographic characteristics included race and ethnicity, age, insurance, religion, language, education, and marital status.
There were 1597 gynecologic oncology studies included in the analysis, 55.3% of which were ovarian cancer studies, 21% cervical cancer studies, 16.4% uterine cancer studies, and 7.3% multisite gynecologic oncology studies. Of studies, 86.3% were interventional and 13.7% were observational.
Demographic data was evaluated in 581 gynecologic oncology manuscripts, with 58% being ovarian cancer manuscripts, 18.9% cervical cancer manuscripts, 17.9% uterine cancer manuscripts, and 5.2% multiple gynecologic site study manuscripts.Age was reported in 95.4% of the studies, while race was only reported in 62.5% and ethnicity in 29.4%.
The number of studies reporting race increased over time. Nineteen studies reported race as broad binary subgroups and 41 only reported race subgroup information online. Of patients, 80% were White, 9% Black, and 3% Asian. Education, marital status, insurance, employment, income, and religion were reported by less than 10% of studies.
Cervical cancer studies were the most likely to report race information at 73.6%, followed by uterine cancer studies at 62.5% and ovarian cancer studies at 58.2%. Similar patterns were observed for ethnicity, at 51.8%, 24%, and 23.4%, respectively.
Among studies reporting race information, White race was reported in 85% of patients in uterine cancer studies, 82% in ovarian cancer studies, and 37% of cervical cancer studies. Overall, the odds of Black patients being represented in ovarian cancer trials compared to White patients decreased 15-fold, 9-fold in uterine cancer trials, and 5-fold in cervical cancer trials.
For Asian and Pacific Islander patients, the odds of being represented in ovarian, uterine, and cervical cancer trials were decreased 27-fold, 8-fold, and 6-fold, respectively. Hispanic patients were 24-fold less likely to be represented in uterine cancer studies and 18-fold in ovarian cancer studies.
These results indicated poor rates of enrollment in gynecologic oncology trials among diverse racial and ethnic populations. Investigators concluded priority alignment, changes in funding mechanisms, and collaboration among sponsors should be utilized to reduce these disparities.
Reference
Lee SS, Dinicu AD, Arthurs L, et al. Demographic reporting and language exclusion in gynecologic oncology clinical trials. Am J Obstet Gynecol. 2024;230:73.e1-14. doi:10.1016/j.ajog.2023.09.019
