Challenges in the Design and Interpretation of Noninferiority Trials Insights From Recent Stent Trials

The noninferiority design is used extensively in current clinical research, but its complex features may hamper the appropriate interpretation of such trials. Thus, understanding the pillars of noninferiority design is indispensable. The authors discuss fundamental concepts regarding the design and interpretation of noninferiority trials and then explore some common methodological criticism by analyzing a sample of contemporary coronary stent trials. Finally, the authors give an overall perspective to enhance the design and conduct of future trials. (C) 2017 by the American College of Cardiology Foundation.