The assumption that comparative effectiveness research will provide timely, relevant evidence rests on changing the current framework for assembling evidence. In this commentary, we provide the background of how coverage decisions for new medical technologies are currently made in the United States. We focus on the statistical issues regarding how to use the ensemble of information for inferring comparative effectiveness. It is clear a paradigm shift in how clinical information is integrated in real-world settings to establish effectiveness is required.
Copyright (c) 2010 John Wiley & Sons, Ltd.