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临床试验中适应性随机化的通用方法。

Generalized method for adaptive randomization in clinical trials.

机构信息

NWORTH, Bangor Clinical Trials Unit, Bangor University, Y Wern, Normal Site, Holyhead Road, Bangor, Gwynedd LL572PZ, UK.

出版信息

Stat Med. 2011 Apr 30;30(9):922-34. doi: 10.1002/sim.4175. Epub 2011 Feb 1.

DOI:10.1002/sim.4175
PMID:21284014
Abstract

A flexible, generalized method of treatment allocation is proposed. The method uses a set of controlling parameters that enables the generic algorithm to produce a family of possible outcomes ranging from simple randomization to deterministic allocation. The method controls balance at stratum level, stratification level and overall without detriment to the predictability of the method. The paper lists the desirable characteristics of allocation methods and shows that the proposed method fulfils the majority and is easy to use in the clinical context, once the coding has been established. An explanation of the method for 2, 3 and 4 treatment group allocations is given. Simulations demonstrate the flexibility of the method.

摘要

提出了一种灵活的、通用的治疗分配方法。该方法使用一组控制参数,使通用算法能够生成一系列可能的结果,从简单的随机化到确定性分配。该方法在层水平、分层水平和整体水平上控制平衡,而不会损害方法的可预测性。本文列出了分配方法的理想特征,并表明在建立编码后,所提出的方法易于在临床环境中使用,且满足大多数要求。给出了用于 2、3 和 4 个治疗组分配的方法解释。模拟结果证明了该方法的灵活性。

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Generalized method for adaptive randomization in clinical trials.临床试验中适应性随机化的通用方法。
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