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