ABSTRACT
A non-inferiority trial attempts to demonstrate that the effect of a treatment is either superior to that of a control or similar to it (Snapinn 2000). The concepts of equivalence and non-inferiority are closely related: in the former case, an important difference between treatments in either direction is of concern, while in the latter case an important difference in one direction is of concern, while any difference in the other direction (toward superiority) is not. Trials evaluating clinical outcomes are more typically classied as non-inferiority trials than equivalence trials, since superiority would not typically be of concern. In some contexts, however, equivalence trials are more common. One such context is bioequivalence, where the objective is to demonstrate that the pharmacokinetic properties of one drug formulation are similar to those of another formulation of the same drug. In addition,
CONTENTS
3.1 Introduction to Non-Inferiority Trials for Efcacy and Safety ............. 39 3.2 Issues in Non-Inferiority Trials ..................................................................43
