Framework conditions facilitating paediatric clinical research

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 populati...

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Autores principales: Knellwolf, Anne-Laure, Bauzon, Stéphane, Alberighi, Ornella Della Casa, Lutsar, Irja, Bácsy, Ernö, Alfarez, Deborah, Panei, Pietro
Formato: Texto
Lenguaje:English
Publicado: BioMed Central 2011
Materias:
Review
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3055809/
https://www.ncbi.nlm.nih.gov/pubmed/21345195
http://dx.doi.org/10.1186/1824-7288-37-12
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author Knellwolf, Anne-Laure
Bauzon, Stéphane
Alberighi, Ornella Della Casa
Lutsar, Irja
Bácsy, Ernö
Alfarez, Deborah
Panei, Pietro
author_facet Knellwolf, Anne-Laure
Bauzon, Stéphane
Alberighi, Ornella Della Casa
Lutsar, Irja
Bácsy, Ernö
Alfarez, Deborah
Panei, Pietro
author_sort Knellwolf, Anne-Laure
collection PubMed
description 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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spelling pubmed-30558092011-03-12 Framework conditions facilitating paediatric clinical research Knellwolf, Anne-Laure Bauzon, Stéphane Alberighi, Ornella Della Casa Lutsar, Irja Bácsy, Ernö Alfarez, Deborah Panei, Pietro Ital J Pediatr Review 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. BioMed Central 2011-02-23 /pmc/articles/PMC3055809/ /pubmed/21345195 http://dx.doi.org/10.1186/1824-7288-37-12 Text en Copyright ©2011 Knellwolf et al; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Review
Knellwolf, Anne-Laure
Bauzon, Stéphane
Alberighi, Ornella Della Casa
Lutsar, Irja
Bácsy, Ernö
Alfarez, Deborah
Panei, Pietro
Framework conditions facilitating paediatric clinical research
title Framework conditions facilitating paediatric clinical research
title_full Framework conditions facilitating paediatric clinical research
title_fullStr Framework conditions facilitating paediatric clinical research
title_full_unstemmed Framework conditions facilitating paediatric clinical research
title_short Framework conditions facilitating paediatric clinical research
title_sort framework conditions facilitating paediatric clinical research
topic Review
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3055809/
https://www.ncbi.nlm.nih.gov/pubmed/21345195
http://dx.doi.org/10.1186/1824-7288-37-12
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AT bacsyerno frameworkconditionsfacilitatingpaediatricclinicalresearch
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