ArticleJCO global oncology2025
Impact of Global Enrollment on Race, Ethnicity, and Age Representation in Pivotal Gynecologic Cancer Trials Leading to US Food and Drug Administration Drug Approvals.
Article in JCO global oncology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
3 citing papers in PubMed.
- Durvalumab and cediranib with and without olaparib in recurrent ovarian cancer: a phase II proof-of-concept study.Nature communications · 2026Trial
- Limited inclusion in clinical trials and access to poly (ADP-ribose) polymerase inhibitors in racial and ethnic minority patients with cancer: a narrative review.The oncologist · 2026Review
- Phase II proof-of-concept study of durvalumab and cediranib with and without olaparib in recurrent ovarian cancer.Research square · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
Abstract
purposeTo evaluate the impact of international enrollment in landmark gynecologic cancer (Gyn-Ca) trials that supported the US Food and Drug Administration (FDA) drug approvals.
methodsWe examined the FDA drug approval database for approved Gyn-Ca agents between January 2014 and June 2024. We then extracted clinical trial identifiers supporting these approvals using FDA safety labels. Expected enrollment was calculated using gynecologic disease site incidence data from the US Cancer Statistics Program and compared with actual trial enrollment reported on ClinicalTrials.gov.
resultsFrom 2014 to 2024, 30 Gyn-Ca trials supporting 28 FDA approvals were conducted in US/international (86.7%), international-only (10%), and US-only sites (3.3%) and enrolled 15,294 patients, with 14,053 remaining (74.0% White, 4.1% Black, 12.7% Asian, 8.7% other) after screening for trials not reporting race. Black (-11.0%;
conclusionBlack, 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.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.