ArticleChild and adolescent psychiatry and mental health2008
Pharmaceutical research in paediatric populations and the new EU Paediatric Legislation: an industry perspective.
Article in Child and adolescent psychiatry and mental health, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.
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
11 citing papers in PubMed.
- Three-Dimensionally Printed Paediatric Medicines: Formulation, Process, and Regulatory Considerations.Pharmaceutics · 2025Review
- Safety reporting in neonatal clinical trials: reflections towards optimal, globally relevant approaches.Trials · 2025Article
- Development of an infant colon simulatingMicrobiology spectrum · 2024Article
- Conducting Drug Treatment Trials in Children: Opportunities and Challenges.Pharmaceutical medicine · 2024Review
- Recommendations by the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA) Working Group on preparedness of clinical trials about paediatric medicines process.Archives of disease in childhood · 2021Review
- Academic pediatric clinical research: factors associated with study implementation duration.BMC medical research methodology · 2016Article
- Article
- Drug development in pediatric psychiatry: current status, future trends.Child and adolescent psychiatry and mental health · 2012Article
- The availability and age-appropriateness of medicines authorized for children in The Netherlands.British journal of clinical pharmacology · 2011Article
- Drug Development for Pediatric Populations: Regulatory Aspects.Pharmaceutics · 2010Review
- Recent developments and strategies in pediatric pharmacology research in the USA.Child and adolescent psychiatry and mental health · 2008Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
1 author.
Funding
No grant is acknowledged in the PubMed record.
Abstract
A large proportion of medicines used in children are prescribed off-label, and children have often been denied access to new or innovative medications. Because such situation is unethical, the need to obtain paediatric information for medicines used in children seems nowadays a matter of consensus on a global basis. Based on this, it was clear in EU, like what has happened in the US, that there was a need for a legal obligation for Pharmaceutical Companies to perform studies. This new European Paediatric Regulation that entered into force in 2007 opens a new era of European drug regulatory history and will offer a major opportunity to improve children's health through advancements in research by providing a new framework for evaluating the efficacy and safety of medicines for children. But, paediatric development remains challenging and the hurdles of conducting research in paediatric population are numerous. The article presents the new European Paediatric Regulation, illustrates its rationale through paediatric psychopharmacology, and discusses some of its consequences on paediatric research from an industry perspective. Recommendations for further international collaboration are also suggested to make global paediatric development plans.
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.