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灵活规划:关于适应性设计的评论

Plan to be flexible: a commentary on adaptive designs.

作者信息

Shih Weichung Joe

机构信息

Department of Biostatistics, School of Public Health, University of Medicine and Dentistry of New Jersey, USA.

出版信息

Biom J. 2006 Aug;48(4):656-9; discussion 660-2. doi: 10.1002/bimj.200610241.

Abstract

This is a discussion of the following three papers appearing in this special issue on adaptive designs: 'Nested repeated confidence intervals and switching between noninferiority and superiority' by Joachim Hartung and Guido Knapp; 'Confirmatory Seamless Phase II/III Clinical trials with Hypotheses Selection at Interim: General Concepts' by Frank Bretz, Heinz Schmidli, Franz König, Amy Racine and Willi Maurer; and 'Confirmatory Seamless Phase Il/III Clinical Trials with Hypotheses Selection at Interim: Applications and Practical Considerations' by Heinz Schmidli, Frank Bretz, Amy Racine and Willi Maurer.

摘要

本文讨论了发表在本期适应性设计特刊上的以下三篇论文

约阿希姆·哈通和吉多·克纳普所著的《嵌套重复置信区间以及非劣效性与优效性之间的切换》;弗兰克·布雷茨、海因茨·施密利、弗朗茨·柯尼希、艾米·拉辛和维利·毛雷尔所著的《中期进行假设选择的验证性无缝II/III期临床试验:一般概念》;以及海因茨·施密利、弗兰克·布雷茨、艾米·拉辛和维利·毛雷尔所著的《中期进行假设选择的验证性无缝II/III期临床试验:应用与实际考量》。

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