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

• Main Authors: Xiao, Lan (Author), Huang, Qiwen (Author), Yank, Veronica (Author), Ma, Jun (Author)
• Format: Book
• Published: JMIR Publications, 2013-07-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.
• Notes: 1438-8871; 10.2196/jmir.2392
• Keywords: Computer applications to medicine. Medical informatics; R858-859.7; Public aspects of medicine; RA1-1270
• Source: Journal of Medical Internet Research, Vol 15, Iss 7, p e139 (2013)

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.