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’sClinicalTrialsDirectiveonthenumberofacademic drug trials carried out in Denmark. DesignRetrospectivereviewofapplicationsfor drugtrials 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