An easily customized, random allocation system using the minimization method for multi-Institutional clinical trials
An easily customized, random allocation system using the minimization method for multi-Institutional clinical trials
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DOI：
10.1016/s0169-2607(99)00047-4
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发表时间：
2000-05-01
影响因子：
6.1
通讯作者：
Nose, Y
中科院分区：
文献类型：
--
作者：
Kenjo, Y;Antoku, Y;Nose, Y
在随机临床试验中，应将患者随机分配至治疗组，以平衡预后因素的分布。多机构随机临床试验中的随机分配由协调中心进行，独立于主治医生用于其实践的医疗机构。这项研究提供了一个复杂的系统，可以将患者随机分配到治疗组。将Pocock提出的最小化方法应用于该系统，以平衡两个治疗组之间预后因素的分布，即使当登记的患者数量相对较少时也是如此（S. J. Pocock，临床试验中患者治疗的分配，生物统计学35（1979）183-197）。此外，Zelen的方法用于平衡每个机构内分配给两组的患者数量（M。Zelen，临床试验患者的随机化和分层，J.Chron.Dis.27（1974）365-375.）。该系统由用于编写公共网关接口（CGI）脚本的“PERL”语言创建，因此可以很容易地扩展到包括主治医生的数据输入功能以及随机分配功能。该系统在日本的13项胃癌、结肠直肠癌和乳腺癌的多机构随机临床试验中得到有效使用。(C)2000爱思唯尔科学爱尔兰有限公司保留所有权利。
In a randomized clinical trial, random allocation of patients to treatment groups should be done to balance in the distribution of prognostic factors. Random allocation in a multi-institutional randomized clinical trial is conducted by a coordinating center, independent of the medical institution the attending doctor uses for his/her practice. This study provides a sophisticated system for doing an exact random allocation of patients to treatment groups. The minimization method proposed by Pocock was applied to this system to balance the distribution of prognostic factors between two treatment groups, even when the number of registered patients is relatively small (S.J. Pocock, Allocation of patients to treatment in clinical trial, Biometrics 35 (1979) 183-197). Furthermore, Zelen's method is used to balance the number of patients allocated to the two groups within each institution (M. Zelen, The randomization and stratification of patients to clinical trials, J. Chron. Dis. 27 (1974) 365-375.). This system was created by the 'PERL' language for writing common gateway interface (CGI) script, and can therefore, be easily extended to include data entry function by attending doctors as well as the random allocation function. This system is being used effectively in thirteen multi-institutional randomized clinical trials for stomach, colon-rectum and breast cancers in Japan. (C) 2000 Elsevier Science Ireland Ltd. All rights reserved.