Effekten af GCP-direktivet på forskerinitierede kliniske laegemiddelforsøg--sekundaerpublikation

Translated title of the contribution: Effect of the GCP Directive on academic drug trials

Louise Berendt, Cecilia Håkansson, Karin Friis Bach, Kim Dalhoff, Per Buch Andreasen, Lene Grejs Petersen, Elin Andersen, Henrik Enghusen Poulsen

Abstract

Since 2004, adherence to Good Clinical Practice has been mandatory for all clinical drug trials. This was new to the investigator-initiated trials. Our study showed no association between the implementation of the Directive and investigator or industry-initiated trials. However, a steady decline was observed over the entire period. Presumably, the introduction of GCP did not entail a decline because of the presence of GCP units at university hospitals. Thus, researchers can conduct clinical drug trials under the same regulations as drug companies.

Translated title of the contributionEffect of the GCP Directive on academic drug trials
Original languageDanish
JournalUgeskrift for Laeger
Volume170
Issue number33
Pages (from-to)2437-9
Number of pages3
ISSN0041-5782
Publication statusPublished - 11 Aug 2008

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