Study Finds Significant Ethnic Disparities in Enrollment Rates of Gynecologic Clinical Trials

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A recent study published on JAMA has found that there are significant racial and ethnic disparities present within the population of women undergoing treatment for gynecologic cancer.¹ The authors of the study bring attention to other recent findings^2,3 which suggest between 6% and 8% of the US adult population with cancer participates in clinical trials. However, these findings also found that patients from minoritized racial and ethnic groups have a low representation within the 6%-8% figure.

The article also reviews prior research done on the underrepresentation of ethnic groups in these trials, calling for a more inclusive trial population. “These studies highlight the need for data sets that include large numbers of women from underrepresented groups. As such, we examined associations of race and ethnicity with clinical trial enrollment among women with gynecologic cancer using the National Cancer Database (NCDB),” the authors say.¹

Along with findings obtained from the NCDB, additional data used for this study were obtained from the Surveillance, Epidemiology, and End Results Program (SEER), a population-based cancer registry. Participants included women with an endometrial, ovarian, or cervical cancer diagnosed from 2004 to 2019. The ethnicities categorized were American Indian/Alaska Native, Asian, Black, Hispanic (any race), Native Hawaiian/Pacific Islander, White, and other.¹

The study found that out of 562,592 women with endometrial, ovarian, or cervical cancer, clinical trial enrollment was lower among Asian, Black, and Hispanic women compared with White women. The authors also considered underlying factors in their analyses, such as social determinants of health, including area-level income, education, and geographic region.¹

While white women were found to be generally overrepresented or adequately represented for all three of the analyzed cancer types in gynecologic trials, the results found that only Black women with endometrial or cervical cancers were adequately or overrepresented in clinical trials, while being underrepresented in ovarian cancer trials. Further, Asian and Hispanic women were found to be underrepresented across all three of the analyzed cancer types.¹

The article emphasizes the need for further research to understand the specific barriers and facilitators impacting the enrollment of gynecologic oncology patients in clinical trials. As such, there are limitations in the study. “Our analyses are limited by the available data within the NCDB, because we lack information on important patient and oncologic characteristics. Certain data that can affect clinical trial enrollment, including trial phase sponsor or funding source, availability of clinical trials, trial treatments (and whether they ultimately ended up becoming standard of care), and physician characteristics, are unavailable,” the authors say.¹

The findings of the study suggest that there is a clear need to engage women with gynecologic cancer from underrepresented populations to improve enrollment, which can provide more accurate data in clinical trials. A lack of quality data can hinder the development of potentially life-saving therapies.

“Further work aimed at understanding the race-specific barriers and facilitators that impact enrollment of gynecologic oncology patients in clinical trials is imperative,” the authors conclude. “Although we noted lower clinical trial enrollment in multiple minoritized groups, the pathways leading to these outcomes are likely diverse and will require targeted interventions.”¹

References

1. Khadraoui W, Meade CE, Backes FJ, Felix AS. Racial and Ethnic Disparities in Clinical Trial Enrollment Among Women With Gynecologic Cancer. JAMA Netw Open. 2023;6(12):e2346494. doi:10.1001/jamanetworkopen.2023.46494
2. Unger JM, Vaidya R, Hershman DL, Minasian LM, Fleury ME. Systematic review and meta-analysis of the magnitude of structural, clinical, and physician and patient barriers to cancer clinical trial participation. J Natl Cancer Inst. 2019;111(3):245-255. doi:10.1093/jnci/djy221
3. Pittell H, Calip GS, Pierre A, et al. Racial and ethnic inequities in US oncology clinical trial participation from 2017 to 2022. JAMA Netw Open. 2023;6(7):e2322515. doi:10.1001/jamanetworkopen.2023.22515