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

• Published in: Journal of medical Internet research Vol. 15; no. 7; p. np
• Main Authors: Xiao, Lan, Huang, Qiwen, Yank, Veronica, Ma, Jun
• Format: Journal Article
• Language: English
• Published: Toronto Gunther Eysenbach MD MPH, Associate Professor 01.01.2013
• Subjects: Arms; Clinical practice; Clinical randomized controlled trials; Clinical research; Clinical trials; Computer based; Internet; Medicine; Minimization; Prognosis; Randomization; Sampling techniques; Translation
• ISSN: 1438-8871; 1438-8871
• DOI: 10.2196/jmir.2405

Background: 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. Objective: To provide clinical tria lists with a robust, flexible, and readily accessible tool for implementing cova riate-adaptiv biased-coin randomization. Methods: We developed a Web-based random allocation system, MinimRan, that applies Pocock-Sim (for trials with 2 O 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. Results: In this paper, we describe the systemʼs essential statistical and computer programming features and provide as a 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. Conclusions: We expect the system to facilitate the translation of the 3 validated random allocation methods into broad, efficient clinical research practice.