Europe gets nul points for harmony in trials

Schnitzbauer, Andreas
May 2009
BMJ: British Medical Journal (Overseas & Retired Doctors Edition;5/30/2009, Vol. 338 Issue 7706, p1302
Academic Journal
The article explores the problems encountered by the authors in getting approval for their multinational study on rapamycin inhibitor or sirolimus. The study was designed to examine the survival and anti-tumor benefits of sirolimus in patients diagnosed with liver cancer who have received transplants. A directive to promote good practice in conducting clinical trials was passed by the European parliament in April 2001. However, despite such directive which supposedly aimed to harmonize procedures for ethical approval, the authors' experiences in getting approval for the trial made them realize that a wide variation in the ethics process of European Union countries still exists.


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