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 klinischer Studien sollte darüber hinaus das CONSORT Statement (Consolidated Standards of Reporting Trials; Begg et al., 1996; Moher et al., 2001; Altman et al., 2001) beachtet werden (vgl. Appendix II). Das CONSORT Statement gibt eine Empfehlung zur einheitlichen Berichterstattung über klinische Studien, die von vielen renommierten medizinischen Journalen für die Publikation einer klinischen Studie zugrunde gelegt wird.
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Schulgen, G., Kristiansen, S. (2002). Qualitätsanforderungen an die biometrische Planung und Auswertung klinischer Studien. In: Methodik klinischer Studien. Statistik und ihre Anwendungen. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-662-08719-0_14
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