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一种用于序贯临床试验的治疗分配程序。

A treatment allocation procedure for sequential clinical trials.

作者信息

Begg C B, Iglewicz B

出版信息

Biometrics. 1980 Mar;36(1):81-90.

PMID:7370375
Abstract

A dynamic treatment allocation procedure is proposed for clinical trials which require balancing across several prognostic factors. The treatment allocation decision is based on the minimization of a function which is an easily evaluated approximation to the variance of the treatment effect in a linear model relating the outcome variable to the chosen prognostic factors and selected interactions. By use of simulations, the procedure is shown to be superior to ad hoc procedures proposed by Pocock and Simon (1975, Biometrics 31, 103-115), over a variety of reasonable experimental situations. It is shown that it is feasible to evaluate the procedure by hand calculations and that it is extremely easy if a small programmable calculator is available. Practical problems relating to implementation of the procedure are discussed with special reference to multi-institutional clinical trials.

摘要

针对需要在多个预后因素之间进行平衡的临床试验,提出了一种动态治疗分配程序。治疗分配决策基于一个函数的最小化,该函数是在将结果变量与选定的预后因素及选定的相互作用相关联的线性模型中,对治疗效果方差的一个易于评估的近似值。通过模拟表明,在各种合理的实验情况下,该程序优于Pocock和Simon(1975年,《生物统计学》31卷,103 - 115页)提出的临时程序。结果表明,通过手工计算来评估该程序是可行的,如果有小型可编程计算器则极其容易。特别参照多机构临床试验讨论了与该程序实施相关的实际问题。

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A treatment allocation procedure for sequential clinical trials.一种用于序贯临床试验的治疗分配程序。
Biometrics. 1980 Mar;36(1):81-90.
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[Treatment by drawing lots in a therapeutic trial with a balance distribution of prognostic factors: the minimization method].[在预后因素均衡分布的治疗试验中通过抽签进行治疗:最小化法]
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[Randomization for controlled therapeutic trials].[对照治疗试验的随机化]
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Generalized multidimensional dynamic allocation method.广义多维动态分配方法。
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Minimization method for balancing continuous prognostic variables between treatment and control groups using Kullback-Leibler divergence.使用库尔贝克-莱布勒散度平衡治疗组和对照组之间连续预后变量的最小化方法。
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