ArticleJournal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer2017
Thoracic Oncology Clinical Trial Eligibility Criteria and Requirements Continue to Increase in Number and Complexity.
Article in Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 33 papers.
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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.
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Who cites it
33 citing papers in PubMed, 67 citations in OpenAlex.
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- Quantitative evaluation of the impact of relaxing eligibility criteria on the risk-benefit profile of drugs for lung cancer based on real-world data.Thoracic cancer · 2024Article
- Circulomic variables predict pathologic staging preoperatively in treatment-naïve non-small cell lung cancer.Journal of thoracic disease · 2023Article
- Initial Steps in Creating a Patient-Centric Addendum to Clinical Trial Informed Consent Forms.JTO clinical and research reports · 2023Article
- Growth in eligibility criteria content and failure to accrue among National Cancer Institute (NCI)-affiliated clinical trials.Cancer medicine · 2023Article
- Better Late Than Never: Fully Incorporating Oncology Advanced Practice Providers Into Cancer Clinical Trials.JCO oncology practice · 2022Article
- A New Approach to Simplifying and Harmonizing Cancer Clinical Trials-Standardizing Eligibility Criteria.JAMA oncology · 2022Article
- Evaluating the impact of eligibility criteria in first-line clinical trials for follicular lymphoma: a MER/LEO cohort analysis.Blood advances · 2022Article
- Brief Report: Implementation of a Universal Prescreening Protocol to Increase Recruitment to Lung Cancer Studies at a Veterans Affairs Cancer Center.JTO clinical and research reports · 2022Article
- Potential Impact of Revised NCI Eligibility Criteria Guidance: Prior Malignancy Exclusion in Breast Cancer Clinical Trials.Journal of the National Comprehensive Cancer Network : JNCCN · 2022Article
- International Association for the Study of Lung Cancer Study of the Impact of Coronavirus Disease 2019 on International Lung Cancer Clinical Trials.Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer · 2022Article
- Article
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Authors and funding
8 authors at 3 institutions in 1 country.
Funding
Abstract
introductionEligibility criteria and screening procedures are designed to optimize the scientific yield and maximize the safety of clinical trials. However, they may also heighten trial complexity, hinder enrollment, decrease generalizability, and increase costs. We analyzed the types and number of eligibility criteria and screening procedures among thoracic oncology clinical trials sponsored or endorsed by the Eastern Cooperative Oncology Group.
methodsWe identified trials and obtained protocols from the Eastern Cooperative Oncology Group website. Eligibility criteria were grouped and categorized as comorbidity (classified by organ system), administrative requirements, prior treatment, and measurable disease requirements. Associations between trial characteristics and eligibility criteria were analyzed by using the Kruskal-Wallis and Wilcoxon tests.
resultsA total of 74 lung cancer trials activated in 1986-2016 were identified. The total number of eligibility criteria was associated with trial principal therapy (a median of nine for surgical, 18 for radiation, and 20 for medical therapy [p = 0.02]), trial primary end point (a median of 20 for overall survival, 28 for progression-free survival, and 17 for other [p = 0.001]), number of therapies (p = 0.05), and year of activation (a median of 16 for 1986-1995, 19 for 1996-2005, and 27 for 2006-2016 [P < 0.001]). The increase in trial eligibility requirements over time was limited to medical therapy trials. Over time, there was also an increase in blood test screening procedures (p = 0.05) but not in imaging, cardiac assessment, or pulmonary function screening procedures.
conclusionsThe number of eligibility criteria and screening procedures in medical therapy lung cancer clinical trials continues to rise. Continued efforts to simplify protocol eligibility and procedures are warranted to promote trial adherence, enrollment, completion, and generalizability.
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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.