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Lessons From and Cautions About Noninferiority and Equivalence Randomized Trials
Peter C. Gøtzsche, MD, DrMedSci
JAMA. 2006;295:1172-1174.
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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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