Sample size computation for two-sample noninferiority log-rank test.

Sin-Ho Jung; Sun J Kang; Linda M McCall; Brent Blumenstein

doi:10.1080/10543400500265736

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Sample size computation for two-sample noninferiority log-rank test.

Sin-Ho Jung·Sun J Kang·Linda M McCall·Brent Blumenstein

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Abstract

When an experimental therapy is less extensive, less toxic, or less expensive than a standard therapy, we may want to prove that the former is not worse than the latter through a noninferiority trial. In this article, we discuss a modification of the log-rank test for noninferiority trials with survival endpoint and propose a sample size formula that can be used in designing such trials. Performance of our sample size formula is investigated through simulations. Our formula is applied to design a real clinical trial.

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Sin-Ho Jung, Sun J Kang, Linda M McCall, Brent Blumenstein. 2005. Sample size computation for two-sample noninferiority log-rank test.. https://doi.org/10.1080/10543400500265736

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