ArticlePediatrics2016
Discontinuation and Nonpublication of Randomized Clinical Trials Conducted in Children.
Article in Pediatrics, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 85 papers, 5 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
85 citing papers in PubMed, 5 syntheses or guidelines pooled it.
- Time to publication for results of clinical trials.The Cochrane database of systematic reviews · 2024Pooled it
- Providing multimedia information to children and young people increases recruitment to trials: pre-planned meta-analysis of SWATs.BMC medicine · 2023Pooled it
- Registration of published randomized trials: a systematic review and meta-analysis.BMC medicine · 2018Pooled it
- Sequential analysis in neonatal research-systematic review.European journal of pediatrics · 2018Pooled it
- EAP viewpoint on unpublished data from paediatric clinical trials.European journal of pediatrics · 2018Guideline
- Exposure-response modeling for extrapolation from adult to pediatric patients who differ with respect to prognostic factors: Application to everolimus.CPT: pharmacometrics & systems pharmacology · 2021Trial
- Lessons learned from conducting a pragmatic, randomized, crossover trial on robot-assisted gait training in children with cerebral palsy (PeLoGAIT).Journal of pediatric rehabilitation medicine · 2020Trial
- Participant Recruitment and Retention in Remote eHealth Intervention Trials: Methods and Lessons Learned From a Large Randomized Controlled Trial of Two Web-Based Smoking Interventions.Journal of medical Internet research · 2018Trial
- Repurposing Empagliflozin for Duchenne Muscular Dystrophy-Associated Cardiomyopathy: Protocol for a Pharmacokinetics, Safety and Proof-of-Concept Trial in Children.Cardiology and therapy · 2026Article
- Moving toward precision communication in pediatric oncology clinical trials: An outline of a conceptual framework to support caregiver decision-making.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026Article
- Article
- Research waste in total knee arthroplasty studies: an observational study on registered trials.BMJ open · 2026Observational
- Approaches in analyzing predictors of trial failure: a scoping review and meta-epidemiological study.BMC medical research methodology · 2026Article
- Article
- Characteristics and potential predictors of prematurely terminated interventional clinical trials for ovarian cancer in the ClinicalTrials.gov database.BMC cancer · 2025Article
- Comparison of the completed and discontinued pediatric drug clinical trials in Mainland China: a cross-sectional analysis based on the data from 2003 to 2023.BMC pediatrics · 2025Article
- Determinants of clinical trial failure in multiple sclerosis: insights from ClinicalTrials.gov.Research square · 2025Article
- Harmonizing the methodology and metrics definitions across pediatric clinical trials networks, an important step towards better health outcomes in children.Pediatric research · 2025Article
- UK paediatric clinical trial protocols: A review of guidance for participant management and care in the event of premature termination.Clinical trials (London, England) · 2025Review
- Using Simulation to Optimize the Design of Adaptive Clinical Trials.Journal of the American Society of Nephrology : JASN · 2025Article
25 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
2 authors.
Funding
Abstract
backgroundTrial discontinuation and nonpublication represent potential waste in research resources and lead to compromises in medical evidence. Pediatric trials may be particularly vulnerable to these outcomes given the challenges encountered in conducting trials in children. We aimed to determine the prevalence of discontinuation and nonpublication of randomized clinical trials (RCTs) conducted in pediatric populations.
methodsRetrospective, cross-sectional study of pediatric RCTs registered in ClinicalTrials.gov from 2008 to 2010. Data were collected from the registry and associated publications identified (final search on September 1, 2015).
resultsOf 559 trials, 104 (19%) were discontinued early, accounting for an estimated 8369 pediatric participants. Difficulty with patient accrual (37%) was the most commonly cited reason for discontinuation. Trials were less likely to be discontinued if they were funded by industry compared with academic institutions (odds ratio [OR] 0.46, 95% confidence interval [CI] 0.27-0.77). Of the 455 completed trials, 136 (30%) were not published, representing 69 165 pediatric participants. Forty-two unpublished trials posted results on ClinicalTrials.gov. Trials funded by industry were more than twice as likely to result in nonpublication at 24 and 36 months (OR 2.21, 95% CI 1.35-3.64; OR 3.12, 95% CI 1.6-6.08, respectively) and had a longer mean time to publication compared with trials sponsored by academia (33 vs 24 months, P < .001).
conclusionsIn this sample of pediatric RCTs, discontinuation and nonpublication were common, with thousands of children exposed to interventions that did not lead to informative or published findings. Trial funding source was an important determinant of these outcomes, with both academic and industry sponsors contributing to inefficiencies.
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.