ArticleBMJ open2013
Haphazard reporting of deaths in clinical trials: a review of cases of ClinicalTrials.gov records and matched publications-a cross-sectional study.
Article in BMJ open, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 1 of them a synthesis 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
16 citing papers in PubMed, 1 synthesis or guideline pooled it.
- The safety and efficacy of vortioxetine for acute treatment of major depressive disorder: a systematic review and meta-analysis.Systematic reviews · 2015Pooled it
- Article
- Evaluation of consistency in adverse event reporting between trial registry and publications in COVID-19 pharmacological intervention trials.International journal of clinical pharmacy · 2026Article
- Misreporting of Patient-Relevant and Study Design Elements in Anesthesiology Randomized Controlled Trials: An Observational Study.Medical sciences (Basel, Switzerland) · 2025Observational
- Reporting of clinical trial safety results in ClinicalTrials.gov for FDA-approved drugs: A cross-sectional analysis.Clinical trials (London, England) · 2022Article
- A web-based tool for automatically linking clinical trials to their publications.Journal of the American Medical Informatics Association : JAMIA · 2022Article
- Reporting of adverse events, conflict of interest and funding in randomised controlled trials of antibiotics: a secondary analysis.BMJ open · 2021Article
- Principles of research ethics: A research primer for low- and middle-income countries.African journal of emergency medicine : Revue africaine de la medecine d'urgence · 2020Article
- 10-Year Update on Study Results Submitted to ClinicalTrials.gov.The New England journal of medicine · 2019Article
- Better science for safer medicines: the human imperative.Journal of the Royal Society of Medicine · 2018Article
- Article
- ClinicalTrials.gov and Drugs@FDA: A Comparison of Results Reporting for New Drug Approval Trials.Annals of internal medicine · 2016Article
- The proposed rule for U.S. clinical trial registration and results submission.The New England journal of medicine · 2015Article
- Clinicaltrials.gov: Is the Glass Half Full?Hospital pharmacy · 2014Article
- Article
- Reporting discrepancies between the ClinicalTrials.gov results database and peer-reviewed publications.Annals of internal medicine · 2014Article
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
No grant is acknowledged in the PubMed record.
Abstract
contextA participant death is a serious event in a clinical trial and needs to be unambiguously and publicly reported.
objectiveTo examine (1) how often and how numbers of deaths are reported in ClinicalTrials.gov records; (2) how often total deaths can be determined per arm within a ClinicalTrials.gov results record and its corresponding publication and (3) whether counts may be discordant.
designRegistry-based study of clinical trial results reporting.
settingClinicalTrials.gov results database searched in July 2011 and matched PubMed publications. SELECTION CRITERIA: A random sample of ClinicalTrials.gov results records. Detailed review of records with a single corresponding publication.
main outcome measureClinicalTrials.gov records reporting number of deaths under participant flow, primary or secondary outcome or serious adverse events. Consistency in reporting of number of deaths between ClinicalTrials.gov records and corresponding publications.
resultsIn 500 randomly selected ClinicalTrials.gov records, only 123 records (25%) reported a number for deaths. Reporting of deaths across data modules for participant flow, primary or secondary outcomes and serious adverse events was variable. In a sample of 27 pairs of ClinicalTrials.gov records with number of deaths and corresponding publications, total deaths per arm could only be determined in 56% (15/27 pairs) but were discordant in 19% (5/27). In 27 pairs of ClinicalTrials.gov records without any information on number of deaths, 48% (13/27) were discordant since the publications reported absence of deaths in 33% (9/27) and positive death numbers in 15% (4/27).
conclusionsDeaths are variably reported in ClinicalTrials.gov records. A reliable total number of deaths per arm cannot always be determined with certainty or can be discordant with number reported in corresponding trial publications. This highlights a need for unambiguous and complete reporting of the number of deaths in trial registries and publications.
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.