Assessing Noninferiority Randomized Controlled Surgical Trials

Randomized controlled trials (RCTs) are typically designed to evaluate whether one intervention is superior to another. Noninferiority RCTs aim to demonstrate that a new therapy, which may be less burdensome or costly, is not appreciably worse than a comparator. In this chapter we discuss features of noninferiority design and provide a framework for critical appraisal of such trials.