ArticleJournal of the National Cancer Institute2022
Implementing Modernized Eligibility Criteria in US National Cancer Institute Clinical Trials.
Article in Journal of the National Cancer Institute, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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
18 citing papers in PubMed, 22 citations in OpenAlex.
- Cancer Clinical Trial Participant Selection: Does Provider Implicit Bias Play a Role?Journal of racial and ethnic health disparities · 2026Article
- TrialTriage, a Semiautonomous Prescreening Workflow for Resolving Ambiguity in Phase I Oncology Trial Eligibility: Development and Proof-of-Concept Study Using Synthetic Cases.JMIR formative research · 2026Article
- People Living with HIV Eligibility in Canadian Cancer Clinical Trials.Current oncology (Toronto, Ont.) · 2026Article
- Article
- Intracranial metastases from solid tumors: Call to action and consensus from the Society for Neuro-Oncology and American Society of Clinical Oncology collaborative.Neuro-oncology · 2026Review
- Demographic Trends in NCI-sponsored Early-phase Clinical Trials (2000-2023): A Cohort Study.Cancer discovery · 2025Article
- Gynecologic cancer clinical trial eligibility criteria as a marker for equitable clinical trial access.Journal of the National Cancer Institute · 2025Article
- Reducing clinical trial eligibility barriers for patients with MDS: an icMDS position statement.Blood · 2025Article
- Two-to-One Randomization: Rarely Advisable.JCO oncology practice · 2024Article
- Optimizing early phase clinical trial washout periods: a report from the Therapeutic Advances in Childhood Leukemia and Lymphoma consortium.Journal of the National Cancer Institute · 2024Article
- Cancer in People with HIV.Infectious disease clinics of North America · 2024Review
- Recommendations for broadening eligibility criteria in esophagus cancer clinical trials: the mortality disparity of esophagus cancer as a first or second primary malignancy.Journal of thoracic disease · 2024Article
- What Is Ailing Oncology Clinical Trials? Can We Fix Them?Current oncology (Toronto, Ont.) · 2024Review
- Equitable inclusion of diverse populations in oncology clinical trials: deterrents and drivers.ESMO open · 2024Review
- Eligibility and Endpoints for Clinical Trials in Trimodality Therapy for Bladder Cancer.Bladder cancer (Amsterdam, Netherlands) · 2024Article
- An essential goal within reach: attaining diversity, equity, and inclusion for the Journal of the National Cancer Institute journals.JNCI cancer spectrum · 2023Article
- Modified Eligibility Criteria: Patient Access and Subpopulation Applicability vs Efficiency in Drug Development.Journal of the National Cancer Institute · 2022Article
- From Race to Racism and Disparities to Equity: An Actionable Biopsychosocial Approach to Breast Cancer Outcomes.Cancer journal (Sudbury, Mass.)Review
Corrections and comments
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Authors and funding
7 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
In 2018, the Cancer Therapy Evaluation Program (CTEP) at the US National Cancer Institute published new protocol template language that focused on organ function and prior and concurrent cancers in an effort to modernize eligibility criteria for cancer treatment trials. We conducted an analysis of CTEP-supported trials to evaluate the uptake and incorporation of the new language. The analysis included evaluation of 122 protocols approved in the years 2018-2020 for inclusion of the modernized eligibility criteria and consistency with new protocol template language related to 7 major eligibility criteria. These were cardiac function, liver function, kidney function, HIV status, prior and/or concurrent malignancies, treated and/or stable brain metastasis, and new and/or progressive brain metastases. Overall, CTEP trials evaluated in this period demonstrated that eligibility criteria were implemented to a relatively high degree ranging from a low of 54.1% for prior and/or concurrent malignancies to a high of 93.4% for eligibility criteria related to HIV infection. The findings demonstrate that modernized eligibility criteria can be successfully implemented but that consistent implementation requires sustained focused effort. As a result of these findings, CTEP began a new initiative in January 2022 that incorporates a specific review of eligibility criteria for new protocols to promote and improve consistency with the modernization effort.
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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.