DYNAMIC BALANCED RANDOMIZATION FOR CLINICAL-TRIALS
DYNAMIC BALANCED RANDOMIZATION FOR CLINICAL-TRIALS
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DOI：
10.1002/sim.4780122410
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发表时间：
1993-12-30
影响因子：
2
通讯作者：
CALLAGHAN, T
中科院分区：
文献类型：
--
作者：
SIGNORINI, DF;LEUNG, O;CALLAGHAN, T
多中心和/或分层随机临床试验的常见治疗分配方法可能会导致分配到每个治疗组的患者数量之间存在显着差异。当使用最小化方案时，这可能发生在置换区组设计的整体试验中或单个机构/阶层内。这可能会导致结果出现偏差。此外，这些程序是可以预测的，并且可能存在研究者引入的选择偏差。提出了一种易于实施的随机化方法，该方法试图通过平衡分层内和整个试验的治疗分配来克服这些问题。该方法对所有分层级别的治疗分配总数进行连续统计。当患者累积时，应用分层决策规则，如果超过某些预定义的限制，则分配是确定性的，否则是随机的。该方法是Soares和Wu的大棒设计的延伸，与Zelen的关键数字随机化方法以及Nordle和Brantmark的方案有关。模拟研究用于证明使用此方法不会发生其他方案可能出现的重大不平衡，并且选择偏差的可能性大大降低。
Common methods of treatment allocation for multi-centre and/or stratified randomized clinical trials can result in substantial differences between the number of patients allocated to each treatment arm. This can occur in the overall trial for a permuted block design or within individual institutions/strata when using a minimization scheme. This may lead to a bias in the result. Also, these procedures can be predictable, with the possibility of an investigator-introduced selection bias. An easily implemented method of randomization is proposed which attempts to overcome these problems by balancing treatment allocations both within strata and across the trial as a whole. The method keeps a running tally on total treatment allocation numbers at all stratification levels. When a patient accrues a hierarchical decision rule is applied, and the allocation is deterministic if certain pre-defined limits are exceeded, and random otherwise. The method is an extension of the big stick design of Soares and Wu, and is related to both Zelen's key number randomization methods and the schemes of Nordle and Brantmark. Simulation studies are used to demonstrate that major imbalances possible with other schemes do not occur using this method, and that the potential for selection bias is much reduced.