ArticleJournal of the National Cancer Institute2025
Gynecologic cancer clinical trial eligibility criteria as a marker for equitable clinical trial access.
Article in Journal of the National Cancer Institute, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 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
2 citing papers in PubMed.
- Examining recruitment differences by race, ethnicity, and age to a decentralized trial of an internet-delivered intervention for sexual health after breast cancer: the WF-2202 SHINE trial.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026Trial
- Diversity, equity, and inclusion as scientific rigor: progress during challenging times.JNCI cancer spectrum · 2026Article
Corrections and comments
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Authors and funding
5 authors.
Funding
Abstract
backgroundRacial and ethnic minorities remain underrepresented in gynecologic cancer clinical trials despite disproportionately worse oncologic outcomes. Research shows differential racial enrollment patterns because of comorbidity-based exclusion criteria. Our objective was to evaluate contemporary trends in comorbidity-based exclusion criteria among National Cancer Institute-sponsored gynecologic cancer clinical trials and protocol adherence to broadened eligibility criteria guidelines as an assessment of equitable enrollment access.
methodsThe ClinicalTrials.gov registry was queried for National Cancer Institute-sponsored gynecologic cancer clinical trials (1994-2021). Study characteristics and comorbidity-based exclusion criteria were abstracted from protocols. Descriptive statistics and temporal trends were calculated using χ2 testing with STATA v17 software.
resultsAmong 279 clinical trials identified, 65% completed enrollment, 53% were phase II, and 48% focused on ovarian cancer. Pharmaceutical agents (85%) were the primary therapeutic interventions. Several inequitably restrictive exclusion criteria increased over time such as hepatitis infection (17% in 1994-2000 vs 49% in 2015-2021, P < .001) and cardiovascular disease (47% in 1994-2000 vs 66% in 2015-2021, P = .002). A previously rare exclusion, "mental illness and/or social situations," dramatically increased from 5% to 51% (P < .001) over 3 decades. Adherence to broadened eligibility criteria recommendations was mixed. Renal function, cardiovascular disease, and performance status criteria were not broadened, but HIV, prior or concurrent malignancies, and brain metastasis criteria were.
conclusionsSome, but not all, of the known restrictive comorbidity-based exclusion criteria have increased in gynecologic cancer clinical trial design, despite calls for improving racial and ethnic minority representation. Exclusion criteria are critical for trial safety, however, they must be carefully considered given the differential racial impact on eligibility.
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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.