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Abstract

Noninferiority asymptotic statistical tests are frequently used in clinical trials. The “at least as good as” criterion was introduced by Laster et al in 2006 for dichotomous data. In this approach (Laster-Johnson-Kotler [LJK]), the margin of noninferiority is taken as a percentage of the control response rather than a fixed difference. The procedure is seen to be more efficient than the fixed margin approach, yielding smaller sample sizes. Also, the procedure offers several advantages in the design, statistical efficiency, and interpretability of noninferiority trials. However, the LJK procedure has a disadvantage in that its size is much greater than the required nominal significance level (α). In this paper, by using a continuity correction factor, we have adjusted this procedure to solve this drawback.

Keywords

noninferiority dichotomous data test size Laster-Johnson-Kotler test continuity correction

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Continuity Correction for the Laster-Johnson-Kotler Noninferiority Asymptotic Statistical Test for 2 Independent Proportions

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