An easily accessible Web-based minimization random allocation system for clinical trials.

An easily accessible Web-based minimization random allocation system for clinical trials.
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DOI:
10.2196/jmir.2392
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发表时间:
2013-07-19
影响因子:
7.4
通讯作者:
Ma J
Ma J
中科院分区:
医学2区
文献类型:
--
作者:
Xiao L;Huang Q;Yank V;Ma J

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Minimization as an adaptive allocation technique has been recommended in the literature for use in randomized clinical trials. However, it remains uncommonly used due in part to a lack of easily accessible implementation tools. To provide clinical trialists with a robust, flexible, and readily accessible tool for implementing covariate-adaptive biased-coin randomization. We developed a Web-based random allocation system, MinimRan, that applies Pocock–Simon (for trials with 2 or more arms) and 2-way (currently limited to 2-arm trials) minimization methods for trials using only categorical prognostic factors or the symmetric Kullback–Leibler divergence minimization method for trials (currently limited to 2-arm trials) using continuous prognostic factors with or without categorical factors, in covariate-adaptive biased-coin randomization. In this paper, we describe the system’s essential statistical and computer programming features and provide as an example the randomization results generated by it in a recently completed trial. The system can be used in single- and double-blind trials as well as single-center and multicenter trials. We expect the system to facilitate the translation of the 3 validated random allocation methods into broad, efficient clinical research practice.
DOI: 10.1001/2013.jamainternmed.987
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