Noninferiority Study Design: Application to Clinical Trials.

Abstract

The noninferiority trial, a distinct category within randomized controlled trials, is garnering increased attention in medical research. Its unique and evolving role comes to the forefront in scenarios where new treatments, despite not surpassing the efficacy of an existing standard, bring additional benefits such as reduced side effects, enhanced compliance, or cost savings. As the field of surgery witnesses a growing number of published noninferiority trials, it becomes imperative for surgeons to grasp the intricacies of this trial type to accurately decipher and interpret their outcomes.