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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Bibliografiske detaljer
Main Authors: Lambers Heerspink, Hiddo J, Dobre, Daniela, Hillege, Hans L, Grobbee, Diederick E, de Zeeuw, Dick
Format: Artigo
Sprog:Inglês
Udgivet: Blackwell Science Inc 2008
Fag:
Methods in Clinical Pharmacology
Online adgang: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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