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Major report reveals problems with EU Clinical Trials Directive

This article was originally published in SRA

Executive Summary

The European Clinical Trials Directive, which came into force in 2004 with the goal of harmonising the clinical research environment throughout the European Union, has made it more complicated for sponsors to conduct multinational clinical trials. It has also increased the administrative burden for competent authorities evaluating and supervising clinical trial authorisations. These are just two of many findings from a major EU-sponsored project set up to examine how the directive (2001/20/EC) has affected pharmaceutical research in the EU1,2.

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