546 – Recent Advances in Covariate-Adaptive Randomization in Clinical Trials: Statistical, Operational, and Regulatory Aspects

Minimran: A Robust Online System to Implement Minimization in Randomized Clinical Trials

at Palo Alto Medical Foundation Research Institute

Despite its theoretically and empirically supported appeal for being able to achieve balance allocation across multiple prognostic factors, minimization remains uncommonly used in clinical trials owing to a lack of implementation tools. To fill this gap, we have developed a robust, flexible, and readily accessible Web-based treatment allocation system, MinimRan (http://studies.pamfri.org:8080/minimRan/index.jsp), in order to promote broad adoption of minimization into clinical research practice. The system currently provides the Pocock-Simon, two-way, and symmetric Kullback-Leibler divergence (KLD) minimization methods. It can support single- and double-blind trials as well as single-center and multicenter trials. MinimRan's ability to ensure double-blinding through a sophisticated, nevertheless user-friendly, role management capability distinguishes it from other existing minimization websites. MinimRan also has robust data management and report functions that enable researchers continuously monitor the randomization process, detect, prevent and correct errors, and verify randomization results. This paper will showcase MinimRan's core functionalities and discuss future development.