The pros and cons of noninferiority trials.
作者信息
Pocock Stuart J
机构信息
Medical Statistics Unit, Department of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, Keppel Street, London, WC1E 7HT UK.
出版信息
Fundam Clin Pharmacol. 2003 Aug;17(4):483-90. doi: 10.1046/j.1472-8206.2003.00162.x.
Abstract
Noninferiority trials comparing new treatment with an active standard control are becoming increasingly common. This article discusses relevant issues regarding their need, design, analysis and interpretation: the appropriate choice of control group, types of noninferiority trial, ethical considerations, sample size determination and potential pitfalls to consider.
摘要
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