title: Impact of the European Clinical Trials Directive on academic clinical research.
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.
authors.affiliation: European Organisation for Research and Treatment of Cancer, Brussels.
authors.forename: A J
authors.initials: AJ
authors.lastname: Baeyens
mesh_terms: D000046:Academic Medical Centers; D035843:Biomedical Research / Q000941:ethics / Q000331:legislation & jurisprudence* / Q000592:standards*; D002986:Clinical Trials as Topic / Q000941:ethics / Q000331:legislation & jurisprudence* / Q000592:standards*; D004348:Drug Labeling / Q000331:legislation & jurisprudence; D015507:Drugs, Investigational / Q000191:economics; D028741:Ethics Committees, Clinical; D005060:Europe; D006381:Helsinki Declaration; D006805:Human Experimentation / Q000941:ethics / Q000331:legislation & jurisprudence / Q000592:standards; D006801:Humans
chemical_list: D015507:Drugs, Investigational