Implementation of the Clinical Trials Directive: Pitfalls and benefits

Abstract:

After a long policy process, the European Directive on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use was finally officially adopted on 4 April 2001.
It has built upon already existing ethical and scientific quality standards for conducting clinical trials in human subjects that were previously developed and applied in daily clinical research, both within the European Union and internationally and that are better known under the name “Good Clinical Practice”.

Apart from these international standards, most Member States already have regulatory procedures for the initiation and performance of clinical trials in place. With the adoption of a GCP Directive the first step has been taken to harmonise regulatory procedures and the level of patient protection throughout Europe.

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