title: [Effect of the GCP Directive on academic drug trials].
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.
authors.affiliation: Laegemiddelstyrelsen, Rigshospitalet, Klinisk Farmakologisk Afdeling Q7642, Københavns Universitetshospitals GCP-enhed, Hellerup. louber03@geh.regionh.dk
authors.forename: Louise
authors.initials: L
authors.lastname: Berendt
authors.forename: Cecilia
authors.initials: C
authors.lastname: Håkansson
authors.forename: Karin Friis
authors.initials: KF
authors.lastname: Bach
authors.forename: Kim
authors.initials: K
authors.lastname: Dalhoff
authors.forename: Per Buch
authors.initials: PB
authors.lastname: Andreasen
authors.forename: Lene Grejs
authors.initials: LG
authors.lastname: Petersen
authors.forename: Elin
authors.initials: E
authors.lastname: Andersen
authors.forename: Henrik Enghusen
authors.initials: HE
authors.lastname: Poulsen