Randomization Methods Used in Clinical Trials

• Activity Number: 197
• Type: Roundtables
• Date/Time: Monday, August 5, 2013 : 12:30 PM to 1:50 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Dennis Sweitzer*+
• Companies: Medidata Solutions
• Keywords: Clinical Trial ; Randomization ; Covariate ; Response ; covariate adjusted randomization ; survey

Abstract

In health care research, the randomized controlled trial is seen as the gold standard because it ensures selection bias is minimized. However, as studies and technologies becomes more sophisticated, so have methods of randomizing studies, resulting in uncertainty as to which methods are preferred in any given setting, and to what extent newer and more complex methods are actually being implemented in the field. This survey primarily targets clinical trial statisticians in Europe, North America, and China. We ascertain how widely used are various methods within the categories of covariate adjusted, response adjusted, and Bayesian adjusted methods. What are the perceived advantages and disadvantages of each? What factors affect the use of methods (including data capture systems and supply management systems)? How well have the methods worked in practice? In this roundtable discussion, I would like to share preliminary results from the survey and discuss with others their experiences with randomization systems.