Collateral damage or apocalypse now for European academic research
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The bureaucratic burden for academic investigators in Europe has tremendously increased since the implementation of the European Directive 2001/20/EC [1, 2, 3, 4, 5]. This increase neither contributes to patient protection nor to the scientific value of clinical trials. Furthermore, a number of new procedures have been added to the bureaucratic workload necessary before initiating a clinical trial. In this light, the request of the International Committee of Medical Editors (ICMJE) for a publicly accessible registry [6, 7, 8]—although a convincing strategy which adds transparency—also means a further increase in the bureaucratic paperwork for the investigators. The ICMJE member journals state that all trials starting enrolment after 1 July 2005 have to be previously registered in a database, otherwise these journals will refuse to publish the results. The goal of such an initiative is the prevention of undisclosed trials as well as duplicate and selective reporting.
While the merits of...
KeywordsMonopoly Ballistic Missile Healthcare Product Regulatory Agency Academic Investigator Pharmaceutical Manufacturer Association
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