Clinical research in newborn infants: difficulties and specificity.

Détails

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ID Serval
serval:BIB_005B7F37F8CB
Type
Article: article d'un périodique ou d'un magazine.
Sous-type
Synthèse (review): revue aussi complète que possible des connaissances sur un sujet, rédigée à partir de l'analyse exhaustive des travaux publiés.
Collection
Publications
Institution
Production externe
Titre
Clinical research in newborn infants: difficulties and specificity.
Périodique
European Journal of Clinical Pharmacology
Auteur⸱e⸱s
Ligi I., Boubred F., Grandvuillemin I., Simeoni U.
ISSN
1432-1041 (Electronic)
ISSN-L
0031-6970
Statut éditorial
Publié
Date de publication
2011
Peer-reviewed
Oui
Volume
67
Numéro
Suppl 1
Pages
29-32
Langue
anglais
Notes
Publication types: Journal Article ; Review Publication Status: ppublish
Résumé
BACKGROUND: Clinical trials are essential in neonates to evaluate scientifically the efficacy and safety of drugs. However, major specificities condition clinical research in human neonates.
OBJECTIVE: To review specific constraints to be taken into account in neonatal research studies.
METHODS: A review of the literature and contribution of authors' opinions was carried out.
RESULTS AND CONCLUSION: Neonatal specificities that induce obstacles in neonatal studies and proposals are detailed. This review also looks at recommendations recently developed by the European Commission to promote safe and ethical research in neonatology.
Mots-clé
Biomedical Research/ethics, Biomedical Research/methods, Clinical Trials as Topic/ethics, Clinical Trials as Topic/methods, Humans, Infant, Newborn, Neonatology/ethics, Neonatology/methods
DOI
10.1007/s00228-010-0921-3
Pubmed
21085938
Web of science
000290738000004
Création de la notice
22/02/2015 10:01
Dernière modification de la notice
20/08/2019 12:22
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