> Merkliste Sie können Bookmarks mittels Listen verwalten, loggen Sie sich dafür bitte in Ihr SLUB Benutzerkonto ein.
Medientyp: Sonstige Veröffentlichung; E-Artikel Titel: Impact of the ICH E9 Guideline Statistical Principles for Clinical Trials on the Conduct of Clinical Trials in Japan Beteiligte: Hirotsu, Chihiro [Verfasser:in]; Hothorn, Ludwig A. [Verfasser:in] Erschienen: London : SAGE Publications Ltd., 2003 Erschienen in: Therapeutic Innovation & Regulatory Science 37 (2003), Nr. 4 Ausgabe: published Version Sprache: Englisch DOI: https://doi.org/10.15488/3012; https://doi.org/10.1177/009286150303700405 ISSN: 2168-4790 Schlagwörter: Subjective and objective measures ; Random and fixed effects models for centers ; Noninferiority trial Entstehung: Anmerkungen: Diese Datenquelle enthält auch Bestandsnachweise, die nicht zu einem Volltext führen. Beschreibung: This article evaluates the impact of the ICH E9 guideline Statistical Principles for Clinical Trials on the conduct of clinical trials in Japan. In particular, the following Japanese practices in the conduct of clinical trials are discussed in detail from the ethical, statistical, and logical viewpoints: 1. Conducting only one phase 3 multicenter trial with many centers and few subjects per center; 2. Seeking to show noninferiority to an active control rather than superiority to placebo; and 3. Choosing a global assessment variable with a subjective component as the primary endpoint. The influence of public health insurance and the potential number of patients in Japan on various aspects of a trial are discussed. Problems requiring further research are mentioned and points requiring clarification are highlighted. © 2003, Drug Information Association. All rights reserved. Zugangsstatus: Freier Zugang