ArticleTrials2025
Reporting quality of dose-expansion cohorts in trials of anticancer drugs could be improved: a cross-sectional study.
Article in Trials, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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
1 citing paper in PubMed.
- A literature review and reflection on clinical trials: current challenges, future directions, and potential strategies to overcome practical barriers.AME clinical trials review · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
Abstract
backgroundDose-expansion cohort (DEC) has been increasingly used as the pivotal trial to demonstrate preliminary efficacy and safety of target anticancer drugs. We aimed to investigate the reporting quality in the published articles of DECs.
methodsWe retrospectively identified the published articles of DEC pivotal trials of the FDA-approved targeted anticancer drugs between Jan 1st, 2012 and March 31st, 2023. All published articles were evaluated by using the CONSORT Dose-finding Extension (CONSORT-DEFINE) guidance.
resultsForty-one articles on DEC trials were identified, of which 32 (78.0%) were published in journals with a high impact factor (≥ 50). The median proportion of adequately reported items in the evaluated 41 articles was 83.7% (with an interquartile range of 79.1% to 88.4%). Inadequacies were observed in several areas of DEC trial reporting. Specifically, planned cohort size (item 3a8), dose modification and discontinuation (item 5b), sample size calculation (item 7a), interim analysis (item 7b), adjusted analyses (item 12b) for efficacy endpoints, data monitoring (item 26), safety review committee (item 26a), and the role of funders (item 25) were mentioned in only 4 (9.8%), 17 (41.5%), 30 (73.2%), 14 (34.1%), 30 (73.2%), 6 (14.6%), 4 (9.8%), and 12 (29.3%) articles, respectively. Additionally, inconsistencies were noted in the definition of DEC across different articles, revealing irregular naming methods being used.
conclusionsDespite being published in high-impact journals, DEC pivotal trials were inadequately reported. There is still a need to improve the completeness and transparency in reporting DEC trials to facilitate external review and evaluation of the DEC evidence.
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Identifiers
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.