A European Directive for clinical research

Excerpt

After a long process the European Parliament and Council adopted on 4 April 2001 a 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" [1]. Even if physicians and lay people will probably see it, for obvious ethical reasons, as a corpus of laws and regulations aiming at protecting the patients enrolled in trials, the Directive must be interpreted as the will of the Commission to create a common market for medicinal products. To do so the regulations concerning drugs testing and approval in all European countries (Member States) need to be harmonized. This explains why the Directive has been elaborated by the Enterprise General-Directorate, which deals with the "internal" market integration and elaboration of common standards, and is not of the responsibility of the Research Commissioner, for instance. Harmonization of European legislations concerning clinical research is certainly highly desirable. However, those deeply involved in research activities at the bedside, especially the intensivists, may be apprehensive, as Brussels regulations are not usually known for simplicity. Additionally, some provisions of the directive may directly affect ICU research. …