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Korean J Pediatr 2012 November;55(11) :403-407.
Published online 2012 August 18.        doi:
Understanding noninferiority trials
Seokyung Hahn (Hahn SK)
Department of Medicine, Seoul National University College of Medicine, Seoul, Division of Medical Statistics, Medical Research Collaborating Center, Seoul National University Hospital, Seoul, Korea
Corresponding Author: Seokyung Hahn ,Tel: +82-2-740-8911, Fax: +82-2-743-8361, Email:
Copyright © 2012 by The Korean Pediatric Society
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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