An Easily Accessible Web-Based Minimization Random Allocation System for Clinical Trials

• Main Authors: Xiao, Lan, Huang, Qiwen, Yank, Veronica, Ma, Jun
• Format: Article
• Language: English
• Published: JMIR Publications 2013-07-01
• Series: Journal of Medical Internet Research
• Online Access: http://www.jmir.org/2013/7/e139/

BackgroundMinimization 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. ObjectiveTo provide clinical trialists with a robust, flexible, and readily accessible tool for implementing covariate-adaptive biased-coin randomization. MethodsWe 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. ResultsIn 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. ConclusionsWe expect the system to facilitate the translation of the 3 validated random allocation methods into broad, efficient clinical research practice.