BMJ, doi: 10.1136/bmj.39401.470648.BE, (Published 6 December 2007)

Research

Effect of European Clinical Trials Directive on academic drug trials in Denmark: retrospective study of applications to the Danish Medicines Agency 1993-2006

Louise Berendt, pharmacy student1,3, Cecilia Håkansson, pharmacy student1,3, Karin Friis Bach, head2, Kim Dalhoff, consultant3,4, Per Buch Andreasen, consultant2, Lene Grejs Petersen, pharmacist1, Elin Andersen, director of division1, Henrik Enghusen Poulsen, consultant3,4

1 Danish Medicines Agency, DK-2300 Copenhagen, Denmark, 2 GCP Unit, Copenhagen University Hospital, Gentofte Hospital, Hellerup, Denmark, 3 Department of Clinical Pharmacology Q7642 Rigshospitalet, Blegdamsvej 9, DK-2100 Copenhagen, Denmark, 4 Faculty of Health Sciences, University of Copenhagen

Correspondence to: H E Poulsen hepo{at}rh.dk

Objective To determine the impact of the European Union’s Clinical Trials Directive on the number of academic drug trials carried out in Denmark.

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

Review 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.

Conclusion 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.


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