期刊
FUNDAMENTAL & CLINICAL PHARMACOLOGY
卷 17, 期 4, 页码 483-490出版社
WILEY
DOI: 10.1046/j.1472-8206.2003.00162.x
关键词
control groups; equivalence; ethics; noninferiority; randomized clinical trials; trial size
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.
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