ReviewJournal of clinical oncology : official journal of the American Society of Clinical Oncology2015
From Protocols to Publications: A Study in Selective Reporting of Outcomes in Randomized Trials in Oncology.
Review in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 28 papers, 6 of them syntheses that pooled it.
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
28 citing papers in PubMed, 6 syntheses or guidelines pooled it.
- Vitamin D for Painful Diabetic Neuropathy: A Systematic Review and Meta-Analysis of Randomised Controlled Trials.Endocrinology, diabetes & metabolism · 2025Pooled it
- Estimating the prevalence of discrepancies between study registrations and publications: a systematic review and meta-analyses.BMJ open · 2023Pooled it
- Outcome reporting bias in randomized-controlled trials investigating antipsychotic drugs.Translational psychiatry · 2017Pooled it
- Reporting and Guidelines in Propensity Score Analysis: A Systematic Review of Cancer and Cancer Surgical Studies.Journal of the National Cancer Institute · 2017Pooled it
- Pooled it
- Pooled it
- Incidence of Primary End Point Changes Among Active Cancer Phase 3 Randomized Clinical Trials.JAMA network open · 2023Trial
- How publish-or-perish culture drives evidence fragmentation in oncology.Annals of medicine · 2026Article
- Research integrity and transparency in CAM journals: an analysis of publication bias and reporting practices (1995-2023) in four leading journals.Research integrity and peer review · 2026Review
- Introducing the need for a consensus-based framework for protocol modifications to improve trial trustworthiness.BMC medicine · 2026Review
- Trends of Publication of Negative Trials Over Time.Clinical pharmacology and therapeutics · 2025Article
- Design and reporting of phase III oncology trials with prospective biomarker validation.Journal of the National Cancer Institute · 2023Article
- Registry versus publication: discrepancy of primary outcomes and possible outcome reporting bias in child and adolescent mental health.European child & adolescent psychiatry · 2022Observational
- Usefulness of Cochrane Reviews in Clinical Guideline Development-A Survey of 585 Recommendations.International journal of environmental research and public health · 2022Article
- An urgent call to raise the bar in oncology.British journal of cancer · 2021Review
- Article
- Rethinking clinical oncology drug research in an era of value-based cancer care: A role for chemotherapy pathways.Cancer medicine · 2020Review
- Risk of Bias and Quality of Reporting in Colon and Rectal Cancer Systematic Reviews Cited by National Comprehensive Cancer Network Guidelines.Journal of general internal medicine · 2020Article
- Assessment of Frequency and Reporting of Changes in Cancer Trial Design After Initiation of Patient Accrual.JAMA oncology · 2019Article
- Discrepancies in endpoints between clinical trial protocols and clinical trial registration in randomized trials in oncology.BMC medical research methodology · 2018Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors.
Funding
Abstract
purposeThe decision by journals to append protocols to published reports of randomized trials was a landmark event in clinical trial reporting. However, limited information is available on how this initiative effected transparency and selective reporting of clinical trial data.
methodsWe analyzed 74 oncology-based randomized trials published in Journal of Clinical Oncology, the New England Journal of Medicine, and The Lancet in 2012. To ascertain integrity of reporting, we compared published reports with their respective appended protocols with regard to primary end points, nonprimary end points, unplanned end points, and unplanned analyses.
resultsA total of 86 primary end points were reported in 74 randomized trials; nine trials had greater than one primary end point. Nine trials (12.2%) had some discrepancy between their planned and published primary end points. A total of 579 nonprimary end points (median, seven per trial) were planned, of which 373 (64.4%; median, five per trial) were reported. A significant positive correlation was found between the number of planned and nonreported nonprimary end points (Spearman r = 0.66; P < .001). Twenty-eight studies (37.8%) reported a total of 65 unplanned end points; 52 (80.0%) of which were not identified as unplanned. Thirty-one (41.9%) and 19 (25.7%) of 74 trials reported a total of 52 unplanned analyses involving primary end points and 33 unplanned analyses involving nonprimary end points, respectively. Studies reported positive unplanned end points and unplanned analyses more frequently than negative outcomes in abstracts (unplanned end points odds ratio, 6.8; P = .002; unplanned analyses odd ratio, 8.4; P = .007).
conclusionDespite public and reviewer access to protocols, selective outcome reporting persists and is a major concern in the reporting of randomized clinical trials. To foster credible evidence-based medicine, additional initiatives are needed to minimize selective reporting.
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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.