SCDM 2015 conference- Implementation of a Web-based Minimization Algorithm for Patient Allocation in Clinical Trials

Dr. John Podoba, President & CEO of Dacima Software, will be presenting his paper on adaptive randomization titled “Implementation of a Web-based Minimization Algorithm for Patient Allocation in Clinical Trials” at the Society for Clinical Data Management 2015 Annual Conference in Washington, DC (September 20 – 23, 2015).

ABSTRACT

Implementation of a Web-based Minimization Algorithm for Patient Allocation in Clinical Trials

John E Podoba, Ph.D. and Maxime Bergeron, D.E.C.

Randomization and stratification are necessary components for recruitment of patient for most multi-armed clinical trials. The purpose of randomization is to eliminate selection bias and to insure a balance of measured and unobserved covariates between the treatment groups. Block and permuted block randomization with stratification are typically used to avoid selection bias and insure balance of confounding variables. However, randomization may introduce significant imbalances in patient prognostic factors, particularly in trial with smaller sample sizes, and these imbalances can reduce the validity of data analysis. Minimization is an adaptive randomization technique designed to reduce imbalances of prognostic factors between treatment arms. Implementing minimization algorithms involves complex computational work to dynamically compute imbalance scores. Implementing such algorithms is beyond the expertise of most clinical researchers. To simplify the process of implementing minimization, Dacima developed a minimization algorithm using the C# programming language and integrated the code into the web randomization module of the Dacima Clinical Suite Electronic Data Capture software. Simple web-based configuration screens allows you to choose either naive or biased-coin minimization methods, specify a base probability and choose from different distance measures. The easy to use configuration screen allows for rapid and simple setup of minimization for clinical trials.