ArticleEuropean journal of pediatrics2007
Stimulation programs for pediatric drug research--do children really benefit?
Article in European journal of pediatrics, 2007. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 36 papers, 2 of them syntheses that pooled it.
What it found
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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
36 citing papers in PubMed, 2 syntheses or guidelines pooled it, 93 citations in OpenAlex.
- Use of off-label and unlicenced drugs in hospitalised paediatric patients: a systematic review.European journal of clinical pharmacology · 2015Pooled it
- Safety of medical interventions in children versus adults.Pediatrics · 2014Pooled it
- Characterization of children's prospective prescription review and exploration of factors influencing the success of interventions.Therapeutic advances in drug safety · 2025Article
- Guidance for pediatric use in prescription information for novel medicinal products in the EU and the US.PloS one · 2022Article
- Rational Use of Medicine in Children-The Conflict of Interests Story. A Review.Rambam Maimonides medical journal · 2019Review
- Labeling Changes and Costs for Clinical Trials Performed Under the US Food and Drug Administration Pediatric Exclusivity Extension, 2007 to 2012.JAMA internal medicine · 2018Article
- A transdisciplinary team approach to scoping reviews: the case of pediatric polypharmacy.BMC medical research methodology · 2018Article
- Drug utilization in neonatal setting of Pakistan: focus on unlicensed and off label drug prescribing.BMC pediatrics · 2018Observational
- Trends in the number and the quality of trial protocols involving children submitted to a French Institutional Review Board.BMC medical research methodology · 2017Article
- Drug versus placebo randomized controlled trials in neonates: A review of ClinicalTrials.gov registry.PloS one · 2017Article
- Use of off-label nephrology-related drugs in hospitalized pediatric patients: a retrospective study.World journal of pediatrics : WJP · 2016Article
- Academic pediatric clinical research: factors associated with study implementation duration.BMC medical research methodology · 2016Article
- Clinical trials in children.British journal of clinical pharmacology · 2015Review
- Placebo-controlled trials in pediatrics and the child's best interest.Italian journal of pediatrics · 2015Article
- Paediatric clinical pharmacology in the UK.Archives of disease in childhood · 2014Review
- The EU paediatric regulation: still a large discrepancy between therapeutic needs and approved paediatric investigation plans.Paediatric drugs · 2014Article
- Off-label prescribing for allergic diseases in children.The World Allergy Organization journal · 2014Article
- Erosive and cariogenicity potential of pediatric drugs: study of physicochemical parameters.BMC oral health · 2013Article
- The mismatch between the health research and development (R&D) that is needed and the R&D that is undertaken: an overview of the problem, the causes, and solutions.Global health action · 2013Article
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Most drugs that are currently prescribed in pediatrics have not been tested in children. Pediatric drug studies are stimulated in the USA by the pediatric exclusivity provision under the Food and Drug Administration Modernization Act (FDAMA) that grants patent extensions when pediatric labeling is provided. We investigated the effectiveness of these programs in stimulating drug research in children, thereby increasing the evidence for safe and effective drug use in the pediatric population. All drugs granted pediatric exclusivity under the FDAMA were analyzed by studying the relevant summaries of medical and clinical pharmacology reviews of the pediatric studies or, if these were unavailable, the labeling information as provided by the manufacturer. A systematic search of the literature was performed to identify drug utilization patterns in children. From July 1998 to August 2006, 135 drug entities were granted pediatric exclusivity. Most frequent drug groups were anti-depressants and mood stabilizers, ACE inhibitors, lipid-lowering preparations, HIV antivirals, and non-steroidal anti-inflammatory and anti-rheumatic drugs. The distribution of the different drugs closely matched the distribution of these drugs over the adult market, and not the drug utilization by children. Many drug studies in children have been performed since the introduction of the FDAMA. However, children infrequently use the drugs granted pediatric exclusivity. The priorities for pediatric drug research should be set by the need of the patients, not by market considerations.
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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.