Impact of Global Enrollment on Race, Ethnicity, and Age Representation in Pivotal Gynecologic Cancer Trials Leading to US Food and Drug Administration Drug Approvals
Black, Hispanic/Latino, and elderly patients were under-represented in pivotal Gyn-Ca trials, whereas Asian patients were over-represented, compared with expected enrollment proportions. Postmarketing studies on under-represented groups should be considered to assess drug efficacy and safety in these populations.
Authors
- Kristen R. Ibanez (ORCID: https://orcid.org/0000-0002-4602-4804)
- Duncan Donohue (ORCID: https://orcid.org/0000-0002-3137-8773)
- Jung‐Min Lee (ORCID: https://orcid.org/0000-0003-1280-5909)
- Ann Oluloro (ORCID: https://orcid.org/0000-0003-4944-7025)
- Elizabeth M. Swisher (ORCID: https://orcid.org/0000-0003-2331-0434)
- Maheen Khan (ORCID: https://orcid.org/0009-0001-9665-0758)
- Courtney Bowen
Institutions
- National Institutes of Health (US)
- University of Washington (US)
- National Cancer Institute (US)
- Data Management Services (United States) (US)
- Center for Cancer Research (US)
Publication Details
- Journal
- JCO Global Oncology
- Published
- 2025-05-01
- DOI
- https://doi.org/10.1200/go-24-00636
- Citations
- 2
- Primary Topic
- Cancer Genomics and Diagnostics
- Type
- article
- Field-Weighted Citation Impact
- 1.87