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Comparative Analysis of Two Independent Proportions in Non-Inferiority Trials
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 Title & Authors
Comparative Analysis of Two Independent Proportions in Non-Inferiority Trials
Yoon, Min; Kwak, Min-Jung;
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 Abstract
Normal approximation methods under the null hypothesis of no difference are frequently used to test the two independent proportions in non-inferiority trials. However, these tests are not appropriate under the null hypothesis of non-zero difference. We review the likelihood score methods proposed by Miettinen and Nurminen, Farrington and Manning, and Gart and Nam and compare the performance of these tests. The simulation study shows that the likelihood score tests under the null hypothesis of non-zero difference have better performance at a Type I error and power than usual normal approximation methods.
 Keywords
Non-inferiority trial;Miettinen and Nurminen;Farrington and Manning;Gart and Nam;
 Language
Korean
 Cited by
 References
1.
Farrington, C. P. and Manning, G. (1990). Test statistics and sample size formulae for comparative binomial trials with null hypothesis of non-Zero risk difference or non-Unity relative risk, Statistics in Medicine, 9, 1447–1454.

2.
Gart, J. J. and Nam, J. (1988). Approximate interval estimation of the ratio in binomial parameters: A review and corrections for skewness, Biometrics, 44, 323–338.

3.
Gart, J. J. and Nam, J. (1990). Approximate interval estimation of the difference in binomial parameters: correction for skewness and extension to multiple tables, Biometrics, 46, 637–643.

4.
ICH E9 Statistical Principals for Clinical Trials, http://www.ich.org.

5.
Miettinen, O. S. and Nurminen, M. (1985). Comparative analysis of two rates, Statistics in Medicine, 4, 213–226.

6.
PASS(Power Analysis and Sample Size) http://www.ncss.com/pass.html.