Evidence map›Paper›PMID 22826574›Full record

ArticlePediatrics2012

Pediatric versus adult drug trials for conditions with high pediatric disease burden.

Florence T Bourgeois, Srinivas Murthy, Catia Pinto, Karen L Olson, John P A Ioannidis, Kenneth D Mandl

Registry-linked trialOpen access · greenAbstract readComparative Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Pediatrics, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05936853 (The EPigenetic Consequences in Children of Intravenous vs Volatile Anaesthesia for Surgery), which is not on this map. Cited by 71 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
71citing papers in PubMed, 5 pooled it
14.1field-weighted citation impact, top 1% of its field
1 · What the graph read from 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.

2 · The registry

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.

NCT05936853 naactive not recruitingnot on this mapstarted 2023, after this paper: background citation

The EPigenetic Consequences in Children of Intravenous vs Volatile Anaesthesia for Surgery (EPIVA) - A Randomised, Feasibility Trial

TypeinterventionalSponsorUniversity Hospital Southampton NHS Foundation TrustRan2023 to 2026Enrolled16ConditionsHypospadias, Anesthesia, Adverse Effect, Perioperative ComplicationArmsIntravenous approach to anaesthetic maintenance, Inhalational approach to anaesthetic maintenance
3 · Its place in the literature

Who cites it

71 citing papers in PubMed, 5 syntheses or guidelines pooled it, 141 citations in OpenAlex.

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  7. Pharmacokinetics and Safety of Vortioxetine in Pediatric Patients.Journal of child and adolescent psychopharmacology · 2017
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11 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 4 institutions in 2 countries.

Florence T BourgeoisDivision of Emergency Medicine, Children's Hospital Boston, 300 Longwood Ave, Boston, MA 02115, USA. florence.bourgeois@childrens.harvard.edu
Srinivas Murthy
Catia Pinto
Karen L Olson
John P A Ioannidis
Kenneth D Mandl
Harvard University · USHarvard–MIT Division of Health Sciences and Technology · USHospital for Sick Children · CAStanford University · US

Funding

RESEARCH TRAINING IN PEDIATRIC EMERGENCY MEDICINET32HD040128 · NICHD · CHILDREN'S HOSPITAL BOSTON · PI Kenneth D. Mandl · 2001 to 2026
$5.0M
Establishing Surveillance of the Pediatric Evidence Base for Drug TherapyR21HD072382 · NICHD · BOSTON CHILDREN'S HOSPITAL · PI BOURGEOIS, FLORENCE, MANDL, KENNETH D. · 2012 to 2013
$479k
Evolving Clinical Information Libraries: Contextualizing Evidence Based MedicineG08LM009778 · NLM · HARVARD MEDICAL SCHOOL · PI MANDL, KENNETH D. · 2008 to 2010
$356k
NICHD NIH HHS 1R21HD072382NICHD NIH HHS 5T32HD040128NICHD NIH HHS R21 HD072382NICHD NIH HHS T32 HD040128NLM NIH HHS 5G08LM009778NLM NIH HHS G08 LM009778
6 · The paper itself

Abstract

BACKGROUND AND

objectiveOptimal treatment decisions in children require sufficient evidence on the safety and efficacy of pharmaceuticals in pediatric patients. However, there is concern that not enough trials are conducted in children and that pediatric trials differ from those performed in adults. Our objective was to measure the prevalence of pediatric studies among clinical drug trials and compare trial characteristics and quality indicators between pediatric and adult drug trials.

methodsFor conditions representing a high burden of pediatric disease, we identified all drug trials registered in ClinicalTrials.gov with start dates between 2006 and 2011 and tracked the resulting publications. We measured the proportion of pediatric trials and subjects for each condition and compared pediatric and adult trial characteristics and quality indicators.

resultsFor the conditions selected, 59.9% of the disease burden was attributable to children, but only 12.0% (292/2440) of trials were pediatric (P < .001). Among pediatric trials, 58.6% were conducted without industry funding compared with 35.0% of adult trials (P < .001). Fewer pediatric compared with adult randomized trials examined safety outcomes (10.1% vs 16.9%, P = .008). Pediatric randomized trials were slightly more likely to be appropriately registered before study start (46.9% vs 39.3%, P = .04) and had a modestly higher probability of publication in the examined time frame (32.8% vs 23.2%, P = .04).

conclusionsThere is substantial discrepancy between pediatric burden of disease and the amount of clinical trial research devoted to pediatric populations. This may be related in part to trial funding, with pediatric trials relying primarily on government and nonprofit organizations.

Indexed as

Cost of IllnessAdultAge FactorsChildDrug IndustryDrugs, InvestigationalEvidence-Based MedicineFemaleHumansMaleQuality Indicators, Health CareRandomized Controlled Trials as TopicResearch Support as TopicSwedenTreatment OutcomeDrugs, Investigational

Identifiers

PMID22826574
PMCPMC3408692
OpenAlexW2137140815

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.