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Methodological characteristics of academic clinical drug trials - a retrospective cohort study of applications to the Danish Medicines Agency 1993-2005
British Journal of Clinical Pharmacology, 07/29/2010
Berendt L et al. – These study shows that randomisation, definition of primary endpoint, GCP monitoring, and control of medicine compliance form part of a significantly increasing percentage of academic clinical drug trials. This indicates an increase in the quality of academic clinical drug research in Denmark 1993–2005. However, high numbers of unblinded randomised controlled trials and randomised controlled trials utilising unacceptable methods for generation of allocation sequence emphasize the potential for further improvement of trial methodology.
