Understanding noninferiority trials.
10.3345/kjp.2012.55.11.403
- Author:
Seokyung HAHN
1
Author Information
1. Department of Medicine, Seoul National University College of Medicine, Seoul, Division of Medical Statistics, Medical Research Collaborating Center, Seoul National University Hospital, Seoul, Korea. hahns@snu.ac.kr
- Publication Type:Review ; Randomized Controlled Trial ; Clinical Trial ; Controlled Clinical Trial
- Keywords:
Noninferiority trial;
Controlled clinical trials;
Randomized controlled clinical trials;
Clinical trials
- MeSH:
Humans
- From:Korean Journal of Pediatrics
2012;55(11):403-407
- CountryRepublic of Korea
- Language:English
-
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.
