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

David Sotres-Ramos, Yoni Castillo-Tzec, Félix Almendra-Arao

Research output: Contribution to journalArticlepeer-review

Abstract

Noninferiority asymptotic statistical tests are frequently used in clinical trials. The "at least as good as" criterion was introduced by Lasteret alin 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.

Original languageEnglish
Pages (from-to)65-69
Number of pages5
JournalTherapeutic Innovation and Regulatory Science
Volume47
Issue number1
DOIs
StatePublished - Jan 2013

Keywords

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

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