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临床试验中的多重决策程序。

A multiple decision procedure in clinical trials.

作者信息

Chen T T, Simon R

机构信息

Biometric Research Branch, National Cancer Institute, Bethesda, Maryland 20892.

出版信息

Stat Med. 1994;13(5-7):431-46. doi: 10.1002/sim.4780130507.

Abstract

In some multiple treatment arm clinical trials there is an order of preference for the treatments based on secondary considerations like toxicity or cost. In this paper, we consider the case where two or more treatments could have equal prior preference. This formulation includes the problem of comparing several equally preferred experimental treatments to one control, or the comparison of a combination with its components. Our decision procedures will guarantee a high selection probability for the correct treatment(s) when that selection is appropriate. We establish sample size requirements for our decision procedures which can be applied to clinical trials with normal, binomial, or right censored exponential endpoints.

摘要

在一些多治疗组临床试验中,基于毒性或成本等次要考虑因素,对治疗方法存在偏好顺序。在本文中,我们考虑两种或更多治疗方法可能具有同等先验偏好的情况。这种表述包括将几种同等偏好的实验性治疗方法与一种对照进行比较的问题,或者将一种组合与其组成部分进行比较的问题。当选择合适时,我们的决策程序将保证正确治疗方法的高选择概率。我们为决策程序确定了样本量要求,这些要求可应用于具有正态、二项式或右删失指数终点的临床试验。

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