 CommentaryNoninferiority trialsSteven M Snapinn  Merck Research Laboratories, West Point, Pennsylvania, USA  author email corresponding author email
Current Controlled Trials in Cardiovascular Medicine 2000,
1:19-21doi:10.1186/cvm-1-1-019 Abstract
Noninferiority trials are intended to show that the effect of a new treatment is not worse than that of an active control by more than a specified margin. These trials have a number of inherent weaknesses that superiority trials do not: no internal demonstration of assay sensitivity, no single conservative analysis approach, lack of protection from bias by blinding, and difficulty in specifying the noninferiority margin. Noninferiority trials may sometimes be necessary when a placebo group can not be ethically included, but it should be recognized that the results of such trials are not as credible as those from a superiority trial. | 
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