ArticleActa oncologica (Stockholm, Sweden)2025
Treatment group-specific inferences in Phase III Randomized Oncology Trials.
Article in Acta oncologica (Stockholm, Sweden), 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.
- Noncomparative Comparisons: The Paradox of Randomized Noncomparative Trials.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2026Article
- Random Assignment, But Without Comparison: A Missed Opportunity.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 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
No grant is acknowledged in the PubMed record.
Abstract
backgroundEstimation of comparative treatment effects between randomized groups is well-supported in randomized trials. By contrast, treatment group-specific inferences are challenging, as patients are selectively chosen for enrollment, and such inferences are formally discouraged by the CONSORT guidelines. The present study is the first-large scale assessment of the proportion of phase III oncology trials that present treatment group-specific inferences.
methodsPublished phase III randomized oncology trials were screened from ClinicalTrials.gov. Treatment group-specific inferences were defined by the presence of 95% CI or standard error for treatment-specific outcomes.
resultsA total of 774 phase III trials enrolling 568,080 patients were included. Treatment group-specific inferences were present in 58% of trials (446 of 774), and appeared to be increasing over time (adjusted odds ratio for the publication year, 1.11; 95% CI, 1.06 to 1.17; p < 0.0001). Of the remaining 328 trials, 49 (6%) described group-specific outcomes with measures of variability, such as interquartile range, and 279 (36%) provided point estimates only (e.g., median) for group outcomes.
interpretationThe majority of published phase III oncology trials present treatment group-specific inferences. However, this inference lacks statistical support, as patients are not randomly sampled from the underlying population, and conflicts with CONSORT guidelines. While ongoing methodological efforts to improve the transportability of treatment group-specific inferences are promising, conventional attempts to generalize treatment-specific outcomes from randomized trials may be misleading. Instead of inference, treatment group-specific outcomes should be described using measures of variability.
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Registered trials
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