Alain Braillon, MD; Gérard Dubois, MD; Michel Slama, MD
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Braillon A., Dubois G., Slama M.; Registration of Clinical Trials. Ann Intern Med. 2005;142:228. doi: 10.7326/0003-4819-142-3-200502010-00026
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Published: Ann Intern Med. 2005;142(3):228.
TO THE EDITOR:
As a condition of consideration for publication, the International Committee of Medical Journal Editors (ICMJE) will soon require authors to register clinical trials in a public trials registry (1). The intent is to improve reliability and quality of clinical research. But why has the ICMJE created a new definition of clinical trial that differs greatly from the one established by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use? The ICMJE also sets conditions that make http://www.clinicaltrials.gov the only registry that meets its criteria, ignoring the fact that since May 2004, clinical trials conducted in European Union member states must be registered in a European database, EudraCT (2). This registry, supervised by the European Medicines Agency, would not be considered acceptable by ICMJE because it is not accessible to the public. Therefore, European investigators will face multiple registrations. Is this the best way to encourage quick implementation? Finally, since the ICMJE mandates that registries must be accessible to the public at no charge, money will again shift away from clinical investigation itself to registration clerks and quality auditors.The road to hell is paved with good intentions.
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Print ISSN: 0003-4819 | Online ISSN: 1539-3704
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