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Intensive Care Medicine

, Volume 31, Issue 2, pp 271–271 | Cite as

Collateral damage or apocalypse now for European academic research

  • Ernst A. Singer
  • Christiane DrumlEmail author
News

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...

Keywords

Monopoly Ballistic Missile Healthcare Product Regulatory Agency Academic Investigator Pharmaceutical Manufacturer Association 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

References

  1. 1.
    Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. http://pharmacos.eudra.orgGoogle Scholar
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    Abbasi K (2004) Compulsory registration of clinical trials. BMJ 329:637–638CrossRefGoogle Scholar

Copyright information

© Springer-Verlag 2005

Authors and Affiliations

  1. 1.Ethics Committee of the Medical University of ViennaBorschkegasse 8bViennaAustria

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