Sample size and the probability of a successful trial
Sample size and the probability of a successful trial
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DOI：
10.1002/pst.232
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发表时间：
2006-10-01
影响因子：
1.5
通讯作者：
Chuang-Stein, Christy
中科院分区：
文献类型：
--
作者：
Chuang-Stein, Christy
本文描述了统计功效和获得成功试验的概率的概念之间的区别。虽然可以选择非常高的统计功效来检测某种治疗效果，但是如果要检测的治疗效果是基于候选药物的感知能力，则高统计功效不一定转化为高成功概率。关键因素取决于我们对药物提供用于研究的效果的能力的了解。本文讨论了一个框架来计算“平均成功概率”，并演示了治疗效果的不确定性如何影响验证性试验的平均成功概率。它补充了O 'Hagan等人在该杂志上发表的早期工作（Pharmaceutical Statistics 2005; 4：187-201）。计算平均成功概率的计算机代码也包括在内。版权所有C）2006约翰威利父子有限公司。
This paper describes the distinction between the concept of statistical power and the probability of getting a successful trial. While one can choose a very high statistical power to detect a certain treatment effect, the high statistical power does not necessarily translate to a high success probability if the treatment effect to detect is based on the perceived ability of the drug candidate. The crucial factor hinges on our knowledge of the drug's ability to deliver the effect used to power the study. The paper discusses a framework to calculate the 'average success probability' and demonstrates how uncertainty about the treatment effect could affect the average success probability for a confirmatory trial. It complements an earlier work by O'Hagan et al. (Pharmaceutical Statistics 2005; 4:187-201) published in this journal. Computer codes to calculate the average success probability are included. Copyright C) 2006 John Wiley & Sons, Ltd.