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Qualitätsanforderungen an die biometrische Planung und Auswertung klinischer Studien

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Methodik klinischer Studien

Part of the book series: Statistik und ihre Anwendungen ((STATIST))

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Zusammenfassung

Neben generellen statistischen Grundregeln, die bei der Planung, Durchführung und Auswertung klinischer Studien zu beachten sind, gibt es mittlerweile eine Reihe von internationalen Richtlinien und Konventionen. Im folgenden geben wir einen Überblick über die derzeit existierenden wichtigsten Richtlinien mit weltweiter oder europäischer Gültigkeit, die für die biometrische Planung und Auswertung klinischer Studien relevant sind. Für die Publikation randomisierter klinischer Studien sollte darüber hinaus das CONSORT Statement (Consolidated Standards of Reporting Trials) beachtet werden, das ausführlich in Appendix 2 am Ende des Buches dargestellt ist. Das CONSORT Statement gibt eine Empfehlung zur einheitlichen Berichterstattung über randomisierte klinische Studien, die von vielen renommierten medizinischen Journalen für die Publikation einer klinischen Studie zugrunde gelegt wird (Begg et al., 1996; Moher et al., 2001 und 2004; Altman et al., 2001). Aktualisierungen, Übersetzungen und Erweiterungen sind zu finden unter http://www.consort-statement.org. Hervorzuheben ist für unseren Rahmen besonders die Erweiterung zur Berichterstattung über Studien zum Nachweis der Gleichwertigkeit von Behandlungen (Piaggio et al., 2006; vgl. Kapitel 7). Appendix 2 gibt einen Überblick über derzeit vorliegende Publikationsleitlinien.

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Authors and Affiliations

  1. Burgunderweg 1, 78464, Konstanz, Deutschland

    Gabi Schulgen/Kristiansen

  2. Data Science, Nycomed GmbH, Byk-Gulden-Str. 2, 78467, Konstanz, Deutschland

    Sören Kristiansen

Authors
  1. Gabi Schulgen/Kristiansen
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  2. Sören Kristiansen
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Schulgen/Kristiansen, G., Kristiansen, S. (2008). Qualitätsanforderungen an die biometrische Planung und Auswertung klinischer Studien. In: Methodik klinischer Studien. Statistik und ihre Anwendungen. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-540-85136-3_14

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