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Italian Journal of Pediatrics
Published in: Italian Journal of Pediatrics 1/2011

Open Access 01-12-2011 | Review

Framework conditions facilitating paediatric clinical research

Authors: Anne-Laure Knellwolf, Stéphane Bauzon, Ornella Della Casa Alberighi, Irja Lutsar, Ernö Bácsy, Deborah Alfarez, Pietro Panei

Published in: Italian Journal of Pediatrics | Issue 1/2011

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Abstract

The use of unlicensed and "off-label" medicines in children is widespread. Between 50-80% of the medicines currently administered to children have neither been tested nor authorized for their use in the paediatric population which represents approximately 25% of the whole European population. On 26 January 2007, entered into force the European Regulation of Paediatric Medicines. It aims at the quality of research into medicines for children but without subjecting the paediatric population to unnecessary clinical trial. This article addresses ethical and legal issues arising from the regulation and makes recommendations for the framework conditions facilitating the development of clinical research with children.
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Metadata
Title
Framework conditions facilitating paediatric clinical research
Authors
Anne-Laure Knellwolf
Stéphane Bauzon
Ornella Della Casa Alberighi
Irja Lutsar
Ernö Bácsy
Deborah Alfarez
Pietro Panei
Publication date
01-12-2011
Publisher
BioMed Central
Published in
Italian Journal of Pediatrics / Issue 1/2011
Electronic ISSN: 1824-7288
DOI
https://doi.org/10.1186/1824-7288-37-12

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