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http://dx.doi.org/10.3345/kjp.2012.55.11.403

Understanding noninferiority trials  

Hahn, Seokyung (Department of Medicine, Seoul National University College of Medicine, Division of Medical Statistics, Medical Research Collaborating Center, Seoul National University Hospital)
Publication Information
Clinical and Experimental Pediatrics / v.55, no.11, 2012 , pp. 403-407 More about this Journal
Abstract
Noninferiority trials test whether a new experimental treatment is not unacceptably less efficacious than an active control treatment already in use. With continuous improvements in health technologies, standard care, and clinical outcomes, the incremental benefits of newly developed treatments may be only marginal over existing treatments. Sometimes assigning patients to a placebo is unethical. In such circumstances, there has been increasing emphasis on the use of noninferiority trial designs. Noninferiority trials are more complex to design, conduct, and interpret than typical superiority trials. This paper reviews the concept of noninferiority trials and discusses some important issues related to them.
Keywords
Noninferiority trial; Controlled clinical trials; Randomized controlled clinical trials; Clinical trials;
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