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临床试验中的样本量重新估计。

Sample size re-estimation in clinical trials.

作者信息

Proschan Michael A

机构信息

National Institute of Allergy and Infectious Diseases, Bethesda, MD 20892-7609, USA.

出版信息

Biom J. 2009 Apr;51(2):348-57. doi: 10.1002/bimj.200800266.

DOI:10.1002/bimj.200800266
PMID:19358221
Abstract

Adaptive clinical trials are becoming very popular because of their flexibility in allowing mid-stream changes of sample size, endpoints, populations, etc. At the same time, they have been regarded with mistrust because they can produce bizarre results in very extreme settings. Understanding the advantages and disadvantages of these rapidly developing methods is a must. This paper reviews flexible methods for sample size re-estimation when the outcome is continuous.

摘要

适应性临床试验正变得非常流行,因为它们具有灵活性,允许在试验进行过程中对样本量、终点、人群等进行调整。与此同时,它们也受到了质疑,因为在非常极端的情况下可能会产生奇怪的结果。了解这些快速发展的方法的优缺点是必不可少的。本文回顾了在结局为连续性变量时进行样本量重新估计的灵活方法。

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