ArticleEuropean journal of pediatrics2015
Successful private-public funding of paediatric medicines research: lessons from the EU programme to fund research into off-patent medicines.
Article in European journal of pediatrics, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 1 of them a synthesis that pooled it.
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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.
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Who cites it
18 citing papers in PubMed, 1 synthesis or guideline pooled it.
- The effects on clinical trial activity of direct funding and taxation policy interventions made by government: A systematic review.PloS one · 2022Pooled it
- An innovative ethosuximide granule formulation designed for pediatric use: Comparative pharmacokinetics, safety, tolerability, and palatability profile versus reference syrup.Pharmacology research & perspectives · 2023Trial
- Pharmacokinetic study (phase I-II) of a new dobutamine formulation in preterm infants immediately after birth.Pediatric research · 2021Trial
- Trial
- An Update on Pharmacologic Management of Neonatal Hypotension: When, Why, and Which Medication.Children (Basel, Switzerland) · 2024Review
- Partnership of I-ACT for children (US) and European pediatric clinical trial networks to facilitate pediatric clinical trials.Frontiers in pediatrics · 2024Article
- Effects of the Paediatric Regulation funding on the development of off-patent medicines in children.Frontiers in medicine · 2024Article
- Paediatric formulations-part of the repurposing concept?Frontiers in medicine · 2024Article
- European research networks to facilitate drug research in children.British journal of clinical pharmacology · 2022Review
- Challenges in conducting paediatric trials with off-patent drugs.Contemporary clinical trials communications · 2021Article
- Paediatric clinical research in Europe: an insight on experts' needs and perspectives.Contemporary clinical trials communications · 2021Article
- Contribution of Population Pharmacokinetics of Glycopeptides and Antifungals to Dosage Adaptation in Paediatric Onco-hematological Malignancies: A Review.Frontiers in pharmacology · 2021Review
- Drug Utilisation and Off-Label Use on a German Neonatal Intensive Care Unit: A Retrospective Cohort Study and 10-Year Comparison.Pharmacy (Basel, Switzerland) · 2020Article
- Article
- Oral drug absorption in pediatrics: the intestinal wall, its developmental changes and current tools for predictions.Biopharmaceutics & drug disposition · 2017Review
- The future of pediatric research: European perspective.Pediatric research · 2017Article
- Moving toward a paradigm shift in the regulatory requirements for pediatric medicines.European journal of pediatrics · 2016Review
- A Literature Review of the Pharmacokinetics and Pharmacodynamics of Dobutamine in Neonates.Pediatric cardiology · 2016Review
Corrections and comments
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Authors and funding
18 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
unlabelledThe European Paediatric Regulation mandated the European Commission to fund research on off-patent medicines with demonstrated therapeutic interest for children. Responding to this mandate, five FP7 project calls were launched and 20 projects were granted. This paper aims to detail the funded projects and their preliminary results. Publicly available sources have been consulted and a descriptive analysis has been performed. Twenty Research Consortia including 246 partners in 29 European and non-European countries were created (involving 129 universities or public-funded research organisations, 51 private companies with 40 SMEs, 7 patient associations). The funded projects investigate 24 medicines, covering 10 therapeutic areas in all paediatric age groups. In response to the Paediatric Regulation and to apply for a Paediatric Use Marketing Authorisation, 15 Paediatric Investigation Plans have been granted by the EMA-Paediatric Committee, including 71 studies of whom 29 paediatric clinical trials, leading to a total of 7,300 children to be recruited in more than 380 investigational centres.
conclusionNotwithstanding the EU contribution for each study is lower than similar publicly funded projects, and also considering the complexity of paediatric research, these projects are performing high-quality research and are progressing towards the increase of new paediatric medicines on the market. Private-public partnerships have been effectively implemented, providing a good example for future collaborative actions. Since these projects cover a limited number of off-patent drugs and many unmet therapeutic needs in paediatrics remain, it is crucial foreseeing new similar initiatives in forthcoming European funding programmes.
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