Outcome-based Biases and Other Issues Involving Non-inferiority Trials
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*Mark D Rothmann, U. S. Food and Drug Administration 

Keywords: Non-inferiority, Outcome-based bias

There are many factors and pitfalls involving the design, analysis, and conduct of non-inferiority trials, including the estimation of the active control effect in the setting of the non-inferiority trial. This presentation discusses the various issues in the design, analysis and conduct of non-inferiority trials with emphasis on recognizing and potentially dealing with conditional biases associated with the estimation of the active control effect.