ArticlePloS one2016
Ten Years after the International Committee of Medical Journal Editors' Clinical Trial Registration Initiative, One Quarter of Phase 3 Pediatric Epilepsy Clinical Trials Still Remain Unpublished: A Cross Sectional Analysis.
Article in PloS one, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 2 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
14 citing papers in PubMed, 2 syntheses or guidelines pooled it, 21 citations in OpenAlex.
- Time to publication for results of clinical trials.The Cochrane database of systematic reviews · 2024Pooled it
- A systematic review of the processes used to link clinical trial registrations to their published results.Systematic reviews · 2017Pooled it
- Availability of results of clinical trials registered on EU Clinical Trials Register: cross sectional audit study.BMJ medicine · 2024Article
- Missing trial results: analysis of the current publication rate of studies in pediatric dialysis from 2003 to 2020.Pediatric nephrology (Berlin, Germany) · 2023Article
- Decision-making in acute viral bronchiolitis: A universal guideline and a publication gap.PloS one · 2020Article
- FDA orphan drug designations for lysosomal storage disorders - a cross-sectional analysis.PloS one · 2020Article
- Clinical Trials on Diabetic Nephropathy: A Cross-Sectional Analysis.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2019Article
- Article
- Publication status of completed registered studies in paediatric appendicitis: a cross-sectional analysis.BMJ open · 2018Observational
- Delays in the Publication of Important Clinical Trial Findings in Oncology.JAMA oncology · 2018Review
- Sponsorship, conflict of interest, risk of bias, and reporting of participant's flow and baseline demographic information in studies applicable to the federal law to post the results in clinicaltrials.gov.Contemporary clinical trials communications · 2017Article
- Article
- Article
- Non-Publication Is Common among Phase 1, Single-Center, Not Prospectively Registered, or Early Terminated Clinical Drug Trials.PloS one · 2016Article
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 at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionAlthough selective reporting of clinical trial results introduces bias into evidence based clinical decision making, publication bias in pediatric epilepsy is unknown today. Since there is a considerable ambiguity in the treatment of an important and common clinical problem, pediatric seizures, we assessed the public availability of results of phase 3 clinical trials that evaluated treatments of seizures in children and adolescents as a surrogate for the extent of publication bias in pediatric epilepsy.
methodsWe determined the proportion of published and unpublished study results of phase 3 clinical trials that were registered as completed on ClinicalTrials.gov. We searched ClinicalTrials.gov, PubMed, and Google Scholar for publications and contacted principal investigators or sponsors. The analysis was performed according to STROBE criteria.
resultsConsidering studies that were completed before 2014 (N = 99), 75 (76%) pediatric phase 3 clinical trials were published but 24 (24%) remained unpublished. The unpublished studies concealed evidence from 4,437 patients. Mean time-to-publication was 25 SD ± 15.6 months, more than twice as long as mandated.
conclusionTen years after the ICMJE's clinical trials registration initiative there is still a considerable amount of selective reporting and delay of publication that potentially distorts the body of evidence in the treatment of pediatric seizures.
Indexed as
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.