Does the European Clinical Trials Directive really improve clinical trial approval time?

AIMS: To facilitate and improve clinical research within Europe, the European Union (EU) adopted in 2001 the Clinical Trials Directive (EUCTD). The aim of this study was to compare duration between submission of a clinical drug trial application and approval by regulatory authorities in EU countries...

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Detalhes bibliográficos
Main Authors: Lambers Heerspink, Hiddo J, Dobre, Daniela, Hillege, Hans L, Grobbee, Diederick E, de Zeeuw, Dick
Formato: Artigo
Idioma:Inglês
Publicado em: Blackwell Science Inc 2008
Assuntos:
Methods in Clinical Pharmacology
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC2561118/
https://ncbi.nlm.nih.gov/pubmed/18662290
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1111/j.1365-2125.2008.03246.x
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