• Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz · Apr 2009

    [Clinical trials registers. Introduction to the topic and backgrounds].

    • G Antes, G Dreier, H Hasselblatt, A Blümle, and M Schumacher.
    • Deutsches Cochrane Zentrum, Institut für Medizinische Biometrie und Medizinische Informatik, Universitätsklinikum Freiburg, Stefan-Meier-Strasse 26, 79104, Freiburg. antes@cochrane.de
    • Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2009 Apr 1;52(4):459-62.

    AbstractIt is a moral responsibility of those performing clinical studies towards patients, funding organizations, the scientific community and towards the general public to publish the results of clinical trials. Under-reporting of clinical trials with null or even negative results as well as over-reporting of trials with positive results can lead to a biased assessment of (new) treatments, which leads to overestimation of potential benefits and underestimation of potential risks. Comprehensive, publicly accessible clinical trial registries are now widely accepted as an essential tool to fill the information gap. Here, the background for implementing a clinical trials register in Germany is described, whereby publication bias, in particular, is addressed.

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