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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.

DOI:10.1002/bimj.200610241
PMID:16972718
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》。

相似文献

1
Plan to be flexible: a commentary on adaptive designs.灵活规划：关于适应性设计的评论
Biom J. 2006 Aug;48(4):656-9; discussion 660-2. doi: 10.1002/bimj.200610241.
2
How practical are adaptive designs likely to be for confirmatory trials?适应性设计对于确证性试验的实用性如何？
Biom J. 2006 Aug;48(4):644-9; discussion 660-2. doi: 10.1002/bimj.200610242.
3
Confirmatory seamless phase II/III clinical trials with hypotheses selection at interim: opportunities and limitations.中期进行假设选择的验证性无缝II/III期临床试验：机遇与局限
Biom J. 2006 Aug;48(4):650-5; discussion 660-2. doi: 10.1002/bimj.200610248.
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Confirmatory seamless phase II/III clinical trials with hypotheses selection at interim: general concepts.在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
Biom J. 2006 Aug;48(4):623-34. doi: 10.1002/bimj.200510232.
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Confirmatory seamless phase II/III clinical trials with hypotheses selection at interim: applications and practical considerations.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
Biom J. 2006 Aug;48(4):635-43. doi: 10.1002/bimj.200510231.
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Practical guidelines for adaptive seamless phase II/III clinical trials that use Bayesian methods.实用指南：使用贝叶斯方法的适应性无缝二期/三期临床试验
Stat Med. 2012 Aug 30;31(19):2068-85. doi: 10.1002/sim.5326. Epub 2012 Mar 22.
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Confirmatory clinical trials with an adaptive design.采用适应性设计的验证性临床试验。
Biom J. 2006 Aug;48(4):574-85. doi: 10.1002/bimj.200510239.
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Adaptive vs. group sequential self-designing trials.适应性试验与序贯组群自我设计试验
Biom J. 2006 Aug;48(4):710-2; discussion 713. doi: 10.1002/bimj.200610259.
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Group-sequential methods for adaptive seamless phase II/III clinical trials.用于适应性无缝II/III期临床试验的序贯分组方法。
J Biopharm Stat. 2011 Jul;21(4):787-801. doi: 10.1080/10543406.2011.551335.
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Opening the adaptive toolbox.打开适应性工具箱。
Biom J. 2006 Aug;48(4):598-603; discussion 613-22. doi: 10.1002/bimj.200610240.

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Adaptive designs in clinical trials: why use them, and how to run and report them.
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