Healthy Skepticism Library item: 9713

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Publication type: Journal Article

Baeyens AJ.
Impact of the European Clinical Trials Directive on academic clinical research.
Med Law 2004; 23:(1):103-10

Abstract:

With the adoption of the Clinical Trials Directive it was Europe’s intention to make the performance of multi-national clinical trials in Europe easier through the harmonization of the regulatory procedures. As the Directive was mainly conceived to facilitate the performance of multi-national clinical trials to develop new drugs, it is to be determined to what extent academic clinical trials will be concerned by the Directive and more importantly what will be its impact on daily academic clinical research. Contrary to several national regulations the scope of the Directive is very large only excluding non-interventional trials. This implies that most of the academic clinical trials will be concerned by the Directive. Besides the handling of the regulatory procedures in the different countries, issues related to insurance, labeling requirements and provision of the investigational medical products will expose the academic sponsor to additional administrative and financial challenges that will have to be handled appropriately, as the academic sponsors will be controlled by Inspectors regarding their compliance with the new regulations to come.

Keywords:
Academic Medical Centers Biomedical Research/ethics Biomedical Research/legislation & jurisprudence* Biomedical Research/standards* Clinical Trials/ethics Clinical Trials/legislation & jurisprudence* Clinical Trials/standards* Drug Labeling/legislation & jurisprudence Drugs, Investigational/economics Ethics Committees, Clinical Europe Helsinki Declaration Human Experimentation/ethics Human Experimentation/legislation & jurisprudence Human Experimentation/standards Humans