Siqueira, Arminda and Whitehead, Anne and Todd, Susan (2008) *Active-control trials with binary data:a comparison of methods for testing superiority or non-inferiority using the odds ratio.* Statistics in Medicine, 27 (3). pp. 353-370. ISSN 1097-0258

## Abstract

This paper considers methods for testing for superiority or non-inferiority in active-control trials with binary data, when the relative treatment effect is expressed as an odds ratio. Three asymptotic tests for the log-odds ratio based on the unconditional binary likelihood are presented, namely the likelihood ratio, Wald and score tests. All three tests can be implemented straightforwardly in standard statistical software packages, as can the corresponding confidence intervals. Simulations indicate that the three alternatives are similar in terms of the Type I error, with values close to the nominal level. However, when the non-inferiority margin becomes large, the score test slightly exceeds the nominal level. In general, the highest power is obtained from the score test, although all three tests are similar and the observed differences in power are not of practical importance.

Item Type: | Article |
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Journal or Publication Title: | Statistics in Medicine |

Uncontrolled Keywords: | binary data ; likelihood ratio test ; non-inferiority ; odds ratio ; score test ; Wald test |

Subjects: | |

Departments: | Faculty of Science and Technology > Mathematics and Statistics |

ID Code: | 52189 |

Deposited By: | ep_importer_pure |

Deposited On: | 21 Dec 2011 10:23 |

Refereed?: | Yes |

Published?: | Published |

Last Modified: | 21 Sep 2017 04:44 |

Identification Number: | |

URI: | http://eprints.lancs.ac.uk/id/eprint/52189 |

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