Analysis CMAJ

Arandomized controlled trial (RCT) canhave either a superiority design or anoninferiority design. A superiority design aims to show that a new drug is better than placebo or an active comparator, whereas a noninferiority design aims to show that a new drug is not worse than its comparator, which is typically an active drug. Noninferiority trials can be used when a new drug is anticipated to have an efficacy profile similar to its comparator and could offer advantages over the existing drug, such as a novel method of administration. We have seen a large increase in publications of noninferiority trials since 2000. A search in PubMed for the term “non-inferior* ” in titles and abstracts found 9 publications in 2000 and 260 publications in 2010. These results show th