The pros and cons of noninferiority trials.
Stuart J Pocock;
(2003)
The pros and cons of noninferiority trials.
Fundamental & clinical pharmacology, 17 (4).
pp. 483-490.
ISSN 0767-3981
DOI: 10.1046/j.1472-8206.2003.00162.x
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.
Item Type | Article |
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Keywords | control groups, equivalence, ethics, noninferiority, randomized, clinical trials, trial size, sample-size formulas, null hypothesis, equivalence, difference, issues |
ISI | 184404600012 |