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. 2008 Aug 11;170(33):2437-9.

[Effect of the GCP Directive on academic drug trials]

[Article in Danish]
Louise Berendt  1 , Cecilia Håkansson, Karin Friis Bach, Kim Dalhoff, Per Buch Andreasen, Lene Grejs Petersen, Elin Andersen, Henrik Enghusen Poulsen
Affiliations
  • PMID: 18761825

[Effect of the GCP Directive on academic drug trials]

[Article in Danish]
Louise Berendt et al. Ugeskr Laeger. .

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.

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