Effect of European Clinical Trials Directive on academic drug trials in Denmark: retrospective study of applications to the Danish Medicines Agency 1993-2006.
OBJECTIVE
To determine the impact of the European Union's Clinical Trials Directive on the number of academic drug trials carried out in Denmark.


METHODS
Retrospective review of applications for drug trials to the Danish Medicines Agency, 1993-2006.


METHODS
Applications for drug trials for alternate years were classified as academic or commercial trials. A random subset of academic trials was reviewed for number of participants in and intended monitoring of the trials.


RESULTS
Academic and commercial drug trials showed an identical steady decline from 1993 to 2006 and no noticeable change after 2004 when good clinical practice became mandatory for academic trials.


CONCLUSIONS
The Clinical Trials Directive introduced in May 2004 to ensure good clinical practice for academic drug trials was not associated with a decline in research activity in Denmark; presumably because good clinical practice units had already been in place in Danish universities since 1999. With such an infrastructure academic researchers can do drug trials under the same regulations as drug companies.
Danish Medicines Agency, DK-2300 Copenhagen, Denmark.
Louise
L
Berendt
Cecilia
C
Håkansson
Karin Friis
KF
Bach
Kim
K
Dalhoff
Per Buch
PB
Andreasen
Lene Grejs
LG
Petersen
Elin
E
Andersen
Henrik Enghusen
HE
Poulsen
D002986:Clinical Trials as Topic / Q000706:statistics & numerical data*; D003718:Denmark; D015507:Drugs, Investigational; D005062:European Union; D006077:Government Agencies / Q000706:statistics & numerical data; D017387:Investigational New Drug Application / Q000706:statistics & numerical data*; D012189:Retrospective Studies
D015507:Drugs, Investigational