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Peter C. Gøtzsche, MD, DrMedSci

JAMA. 2006;295:1172-1174.

	Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

The design of the classic, parallel-group randomized trial involves formulating a null hypothesis of no difference between 2 interventions and identifying a clinically relevant difference () that researchers do not wish to overlook. Commonly referred to as superiority trials, the investigators usually hope to be able to reject the null hypothesis and demonstrate a difference between interventions. In contrast, a noninferiority trial is one-sided in nature¹ as it seeks to determine whether a new intervention is no worse than a reference intervention within a prespecified noninferiority interval (– to 0) for the primary outcome. Similarly, an equivalence trial aims to determine whether 2 interventions have a similar effect, within a prespecified interval (– to + ).

Noninferiority and equivalence randomized trials create challenges for researchers and clinicians and are associated with several issues that are controversial and difficult to grasp, even for trialists. Two reports . . . [Full Text of this Article]

Author Affiliation: Nordic Cochrane Centre, Copenhagen, Denmark.

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