In 2004, when the CT directive came into force, the GCP-rules became mandatory for the independent researchers and they were to meet the same requirements as their colleagues in the pharmaceutical industry - something which led many people to fear that it would result in less public research. The Danish Medicines Agency has contributed to a new study which shows that the directive on Good Clinical Practice has not reduced the number of clinical trials.
The enhanced requirements in the so-called CT directive equals extra work in the form of additional documentation and monitoring. When it was extended to comprise researchers at e.g. university hospitals in 2004, it caused a great deal of debate as to whether the increased resource requirement would result in fewer clinical trials initiated by researchers.
The study comprises the total number of applications for clinical trials with medicinal products submitted to the Danish Medicines Agency in the period 1993 to 2006. From 1993 to 2005, there was a steady downward trend in the number of clinical trials initiated by both researchers and companies, while the number increased in 2006.
The study therefore concludes that clinical trials initiated by researchers can comply with the GCP on a par with trials initiated by companies.
Rigshospitalet, Copenhagen University Hospital, University of Copenhagen and the Danish Medicines Agency have collaborated on the study.
In the factbox to the right, you can find the links to some articles about the study that were published in the British Medical Journal1 and the Journal of the Danish Medical Association2 (in Danish).
For further information about the study, please contact Lene Grejs Petersen on tel.: +45 4488 9305 or by e-mail: lgp@dkma.dk.
Danish Medicines Agency, 18 August 2008
1) Berendt et al: Effekten af GCP-direktivet på forskerinitierede kliniske lægemiddelforsøg (Ugeskrift for Læger, 2008;170(33):2437)
2) Berendt et al: Effect of European Clinical Trials Directive on academic drug trials in Denmark: retrospective study of applications to the Danish Medicines Agency 1993-2006 (British Medical Journal www.bmj.com 2008;336:33-35).
