The conduct of clinical trials for medicinal products in europe in the light of the European clinical trials directive. Review of regulatory and practical aspects in the different countries.
The purpose of the clinical trial guidelines is to harmonise legislation in order to ensure consistency within Europe and thereby promote Europe's attractiveness for clinical research while maintaining or improving the protection of subjects who agree to participate. The French administrative system has hitherto been relatively favourable (with simple notification to a single Ethics Committee per study); it is thus important to maintain competitiveness in these respects, given that, in other areas (the time it takes to establish agreements, recruitment, etc.), other countries have the advantage. At the moment, this Directive has not been entirely transposed into French law. The pilot period established by the Afssaps (French drug agency) has made it possible to determine very quickly how to set things up. For Ethics Committees, the situation is more critical in that many points remain that need to be finalised (selection of members, internal rules, Competent Authority/Ethics Committee relationship, etc.). The Giens workshop issued a number of proposals and it hopes, through the Afssaps)/DGS (French agency of health in government)/LEEM Steering Group (French pharmaceutical companies association), to be able to help establish an efficient system which also correctly protect the patient.
Dubray
Claude
C
Pharmacologie Clinique, CHU Clermont Ferrand, Clermont Ferrand, France.
Maillere
Patricia
P
Spriet
Alain
A
D035843:Biomedical Research / Q000191:economics / Q000941:ethics / Q000331:legislation & jurisprudence / Q000592:standards* / Q000639:trends*; D028744:Ethics Committees, Research; D005060:Europe; D005249:Fees and Charges; D005602:France; D017408:Guidelines as Topic; D006801:Humans; D011358:Product Surveillance, Postmarketing; D012042:Registries