ArticleBMJ paediatrics open2019
Reporting of data monitoring committees and adverse events in paediatric trials: a descriptive analysis.
Article in BMJ paediatrics open, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.
What it found
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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
6 citing papers in PubMed.
- Consistency Between Clinical Trial Registry Entries and Journal Publications in Transfusion Medicine: An Observational Study.Journal of clinical medicine · 2026Article
- Behavior-change lifestyle interventions for the treatment of obesity in children and adolescents: A scoping review.Annals of the New York Academy of Sciences · 2025Article
- Safety reporting in trials on glaucoma interventions registered in ClinicalTrials.gov and corresponding publications.Scientific reports · 2024Article
- Ethical preparedness of data monitoring committees (DMCs) to oversee international clinical trials: a qualitative descriptive study.BMJ global health · 2024Article
- Data monitoring committees in pediatric randomized controlled trials registered in ClinicalTrials.gov.Clinical trials (London, England) · 2023Article
- Fake news and fake research: Why meta-research matters more than ever.Journal of paediatrics and child health · 2020Article
Corrections and comments
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Authors and funding
11 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesFor 300 paediatric trials, we evaluated the reporting of: a data monitoring committee (DMC); interim analyses, stopping rules and early stopping; and adverse events and harm-related endpoints.
methodsFor this cross-sectional evaluation, we randomly selected 300 paediatric trials published in 2012 from the Cochrane Central Register of Controlled Trials. We collected data on the reporting of a DMC; interim analyses, stopping rules and early stopping; and adverse events and harm-related endpoints. We reported the findings descriptively and stratified by trial characteristics.
resultsEighty-five (28%) of the trials investigated drugs, and 18% (n=55/300) reported a DMC. The reporting of a DMC was more common among multicentre than single centre trials (n=41/132, 31% vs n=14/139, 10%, p<0.001) and industry-sponsored trials compared with those sponsored by other sources (n=16/50, 32% vs n=39/250, 16%, p=0.009). Trials that reported a DMC enrolled more participants than those that did not (median [range]): 224 (10-60480) vs 91 (10-9528) (p<0.001). Only 25% of these trials reported interim analyses, and 42% reported stopping rules. Less than half (n=143/300, 48%) of trials reported on adverse events, and 72% (n=215/300) reported on harm-related endpoints. Trials that reported a DMC compared with those that did not were more likely to report adverse events (n=43/55, 78% vs 100/245, 41%, p<0.001) and harm-related endpoints (n=52/55, 95% vs. 163/245, 67%, p<0.001). Only 32% of drug trials reported a DMC; 18% and 19% did not report on adverse events or harm-related endpoints, respectively.
conclusionsThe reporting of a DMC was infrequent, even among drug trials. Few trials reported stopping rules or interim analyses. Reporting of adverse events and harm-related endpoints was suboptimal.
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Registered trials
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