Clinical and Experimental Pediatrics

The Korean Pediatric Society (대한소아청소년과학회)
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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)
  • Received : 2012.06.29
  • Accepted : 2012.08.18
  • Published : 2012.11.15
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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

References

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