Enrollment representation of age, race, and ethnicity in ovarian cancer registrational clinical trials (2010-2020): An evaluation by the U.S. Food and Drug Administration.

Abstract

e18527 Background: Ovarian cancer is the fifth leading cause of cancer mortality among U.S. women. Because clinical trials have historically not been demographically representative of real-world patients, an understanding of the extent of disparities is an important step in addressing them. We aimed to evaluate the representation of older adults and racial and ethnic minorities in trials for ovarian cancer drugs. Methods: We conducted a pooled analysis of all trials that were submitted to the U.S. Food and Drug Administration (FDA) from January 1, 2010 to December 31, 2020 in support of marketing applications for epithelial ovarian, fallopian tube, or primary peritoneal indications. Demographic data (age, race, and ethnicity) for adult participants were analyzed alongside incident ovarian cancer case data (diagnosis between 2010 and 2019) from the National Cancer Institute Surveillance, Epidemiology, and End Results (SEER) Program. Enrollment to Incidence Ratio (EIR) is reported and defined as the percentage of participants divided by percentage of U.S. incident ovarian cancer cases. An EIR between 0.80-1.20 indicates adequate representation; <0.80 or >1.20 indicates underrepresentation or overrepresentation, respectively. Participants with race or ethnicity categories reported as unknown or missing, or insufficient for calculation were not included in this analysis. A sensitivity analysis was conducted to evaluate the exclusion of trials enrolling only BRCA+ participants. Results: The analysis included 8,211 participants enrolled across 15 clinical trials. Age was available for all participants; race/ethnicity was not reported for 16.3% of participants. With increasing age, EIR decreased (Table). Non-Hispanic (NH) White participants had the highest EIR of all racial/ethnic groups, while NH Black and Hispanic participants had the lowest EIR. Results were similar when excluding trials enrolling only BRCA+ participants. Conclusions: Adults aged ≥75, NH Black, and Hispanic participants were underrepresented in registrational trials for new ovarian cancer therapies. To enhance understanding of the correlation between age, race, and ethnicity, further analyses are necessary. Prospective measures are essential, as discussed in recent FDA guidances, to enroll an adequately representative population in ovarian cancer clinical trials.[Table: see text]