Clinical research in newborn infants: difficulties and specificity.

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Serval ID
serval:BIB_005B7F37F8CB
Type
Article: article from journal or magazin.
Publication sub-type
Review (review): journal as complete as possible of one specific subject, written based on exhaustive analyses from published work.
Collection
Publications
Institution
Production externe
Title
Clinical research in newborn infants: difficulties and specificity.
Journal
European Journal of Clinical Pharmacology
Author(s)
Ligi I., Boubred F., Grandvuillemin I., Simeoni U.
ISSN
1432-1041 (Electronic)
ISSN-L
0031-6970
Publication state
Published
Issued date
2011
Peer-reviewed
Oui
Volume
67
Number
Suppl 1
Pages
29-32
Language
english
Notes
Publication types: Journal Article ; Review Publication Status: ppublish
Abstract
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.
Keywords
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
Create date
22/02/2015 10:01
Last modification date
20/08/2019 12:22
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