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.

Authors

null

Felice Yang

Oncology Center of Excellence, Office of the Commissioner, U.S. Food and Drug Administration, Silver Spring, MD

Felice Yang , Yue Huang , Catherine Lerro , Wei Liu , Mallorie Fiero , Zhou Feng , Bindu Kanapuru , Timil Patel , Laleh Amiri-Kordestani , Gwynn Ison , Lola A. Fashoyin-Aje , Paul Kluetz , Harpreet Singh , Donna Rivera

Organizations

Oncology Center of Excellence, Office of the Commissioner, U.S. Food and Drug Administration, Silver Spring, MD, Office of Biostatistics, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, Office of Oncologic Diseases, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, Oncology Center of Excellence, U.S. Food and Drug Administration; Office of Oncologic Diseases, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, Oncology Center of Excellence, Office of the Commissioner, U.S. Food and Drug Administration; Office of Oncologic Diseases, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD

Research Funding

No funding received
None.

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.

Clinical trial enrollment and SEER incident cases by age and race/ethnicity group.

Trial Participants (%)SEER Incidence (%)EIR (95% CI)
Age20-6465.5051.271.28 (1.26, 1.30)
65-6916.0614.021.15 (1.09, 1.20)
70-7410.8612.110.90 (0.84, 0.96)
≥757.5822.600.34 (0.31, 0.36)
Race/EthnicityNH White86.2268.931.25 (1.24, 1.26)
NH Black2.779.170.30 (0.26, 0.35)
NH Asian/Pacific Islander6.577.330.90 (0.82, 0.98)
Hispanic4.4414.580.30 (0.27, 0.34)

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Abstract Details

Meeting

2023 ASCO Annual Meeting

Session Type

Publication Only

Session Title

Publication Only: Health Services Research and Quality Improvement

Track

Quality Care/Health Services Research

Sub Track

Access to Care

Citation

J Clin Oncol 41, 2023 (suppl 16; abstr e18527)

DOI

10.1200/JCO.2023.41.16_suppl.e18527

Abstract #

e18527

Abstract Disclosures