ArticlePediatrics2012
Status of the pediatric clinical trials enterprise: an analysis of the US ClinicalTrials.gov registry.
Article in Pediatrics, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 57 papers, 3 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
57 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- Experiences and perspectives of children and adolescents participating in pediatric clinical trials: a qualitative evidence synthesis.Archives of public health = Archives belges de sante publique · 2026Pooled it
- Informed consent approaches for clinical trial participation of infants with minor parents in sub-Saharan Africa: A systematic review.PloS one · 2020Pooled it
- Sample size calculations in pediatric clinical trials conducted in an ICU: a systematic review.Trials · 2014Pooled it
- Parental Engagement in Consent Processes for Enrollment in Biomedical HIV Prevention Trials: Implications for Minor Adolescents' Willingness to Participate.The Journal of adolescent health : official publication of the Society for Adolescent Medicine · 2023Trial
- Journal of child health care : for professionals working with children in the hospital and community · 2022Trial
- Endocrine Effects of Arginine-Vasopressin After Pediatric Cardiac Surgery.Pediatric cardiology · 2026Article
- Integrating Real-World Data and Pharmacometrics to Bridge Evidence Gaps in Special Populations: A State-of-the-Art Review.Pharmaceutics · 2026Review
- Paediatric Phase I/II Clinical Trial Assessments Under the New EU Clinical Trial Regulation: A Descriptive Analysis.Pharmaceutical medicine · 2026Article
- The Global Clinical Trial Landscape for Children and Adolescents With Cancer.JAMA network open · 2026Article
- Benchmarking Transformer Embedding Models for Biomedical Terminology Standardization.Machine learning with applications · 2025Article
- Equity in neuromuscular research: a 20-year analysis of race, ethnicity, sex, and age representation.Journal of neurology · 2025Article
- Characteristics of pediatric interventional drug trials registered between 2015 and 2024 on ClinicalTrials.gov.Frontiers in pediatrics · 2025Article
- Multisource representation learning for pediatric knowledge extraction from electronic health records.NPJ digital medicine · 2024Article
- Direct-to-participant recruitment of mothers and infants: A strategic approach during challenging pandemic times.Contemporary clinical trials communications · 2024Article
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- Article
- A comprehensive review and characterization of nasopharyngeal carcinoma clinical trials.World journal of otorhinolaryngology - head and neck surgery · 2023Article
- Multisystem inflammatory syndrome drug treatment in countries with different income profiles: a scoping review.Frontiers in pharmacology · 2023Article
- Traumatic injury clinical trial evaluating tranexamic acid in children (TIC-TOC): A pilot randomized trial.Academic emergency medicine : official journal of the Society for Academic Emergency Medicine · 2022Article
- Considerations for Selecting Cognitive Endpoints and Psychological Patient-Reported Outcomes for Clinical Trials in Pediatric Patients With Sickle Cell Disease.Frontiers in neurology · 2022Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
Abstract
BACKGROUND AND
objectivesClinical trials are the gold standard for generating evidence-based knowledge in medicine. Recent legislation requiring trials to be registered at ClinicalTrials.gov has enabled evaluation of the clinical trial enterprise as a whole, which was previously not possible. The purpose of this study was to create a snapshot of the pediatric clinical trial portfolio.
methodsAll interventional trials registered at ClinicalTrials.gov from July 2005 to September 2010 were included. Pediatric (ie, enrolling patients aged 0-18 years) trial characteristics, therapeutic area, location, and funding were described. Secondary objectives included describing pediatric trials over time and comparison with nonpediatric trials.
resultsDuring this time, 5035 pediatric trials were registered compared with >10 times as many nonpediatric trials. Neonates/infants were eligible for enrollment in 46.6% of trials versus children (77.9%) and adolescents (45.2%). Nearly one-half of pediatric trials enrolled <100 subjects, and more pediatric trials versus nonpediatric trials evaluated preventive therapies. The proportion of pediatric trials evaluating a drug intervention declined over time, and there were fewer Phase 0 to II versus Phase III to IV trials. Infectious disease/vaccine studies (23%) were the most common, followed by psychiatric/mental health (13%) studies. Many trials enrolled patients outside the United States, and <15% of trials were sponsored by the National Institutes of Health or other US federal agencies.
conclusionsAnalysis of the ClinicalTrials.gov data set allows description of the current scope of pediatric trials. These data may be useful to stakeholders in informing decisions regarding the conduct of trials in children and provide insight into mechanisms to advance pediatric trial infrastructure and methodology toward improving child health.
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.