The Swiss regulatory framework for pædiatric health research

Details

Serval ID
serval:BIB_59893923B739
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
The Swiss regulatory framework for pædiatric health research
Journal
European Journal of Health Law
Author(s)
Junod V.
ISSN
0929-0273
Publication state
Published
Issued date
2008
Peer-reviewed
Oui
Volume
15
Number
2
Pages
183-195
Language
english
Abstract
Medical research on minors entails both risks and benefits. Under Swiss law, clinical trials on children, including nontherapeutic drug trials, are permissible. However, ethics committees must systematically verify that all clinical studies have a favorable risk-benefit profile. Additional safeguards are designed to ensure that children are not unnecessarily involved in research and that proper consent is always obtained. Federal Swiss law is undergoing revision to extend these protections beyond clinical trials to a broad array of health research. The Swiss drug agency also seeks to improve the incentives for pharmaceutical firms to develop new paediatric drugs and relevant paediatric drug labels.
Keywords
Pharmaceutical regulation, Ethics committees, Data protection, Swiss law, Paediatric studies, Clinical trials, Drug research
Create date
17/08/2009 9:53
Last modification date
20/08/2019 15:13
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