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Does the European clinical trials directive really improve clinical trial approval time?

Authors
  • Lambers Heerspink, Hiddo J
  • Dobre, Daniela
  • Hillege, Hans L
  • Grobbee, Diederick E
  • de Zeeuw, Dick
Type
Published Article
Journal
British Journal of Clinical Pharmacology
Publisher
Wiley (Blackwell Publishing)
Publication Date
Oct 01, 2008
Volume
66
Issue
4
Pages
546–550
Identifiers
DOI: 10.1111/j.1365-2125.2008.03246.x
PMID: 18662290
Source
Medline
License
Unknown

Abstract

In this early stage of implementation, EUCTD appears not to shorten the duration of regulatory procedures for clinical trial initiation. Furthermore, Europe lags behind the USA in speed of regulatory procedures.

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