A more powerful exact test of noninferiority from binary matched-pairs data

Chris J. Lloyd, Max Moldovan

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31 Citations (Scopus)


Assessing the therapeutic noninferiority of one medical treatment compared with another is often based on the difference in response rates from a matched binary pairs design. This paper develops a new exact unconditional test for noninferiority that is more powerful than available alternatives. There are two new elements presented in this paper. First, we introduce the likelihood ratio statistic as an alternative to the previously proposed score statistic of Nam (Biometrics 1997; 53:1422-1430). Second, we eliminate the nuisance parameter by estimation followed by maximization as an alternative to the partial maximization of Berger and Boos (Am. Stat. Assoc. 1994; 89:1012-1016) or traditional full maximization. Based on an extensive numerical study, we recommend tests based on the score statistic, the nuisance parameter being controlled by estimation followed by maximization.

Original languageEnglish
Pages (from-to)3540-3549
Number of pages10
JournalStatistics in Medicine
Issue number18
Publication statusPublished or Issued - 15 Aug 2008
Externally publishedYes


  • Exact tests
  • Noninferiority
  • Nuisance parameters

ASJC Scopus subject areas

  • Epidemiology
  • Statistics and Probability

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