A fiducial approach for testing the non-inferiority of proportion difference in matched-pairs design

Pharm Stat. 2023 May-Jun;22(3):520-530. doi: 10.1002/pst.2288. Epub 2023 Jan 5.

Abstract

The non-inferiority of one treatment/drug to another is a common and important issue in medical and pharmaceutical fields. This study explored a fiducial approach for testing the non-inferiority of proportion difference in matched-pairs design. Approximate tests constructed using fiducial quantities with a combination of different parameters were proposed. Four simulation studies were employed to compare the performance of fiducial tests by comparing their type I errors and powers. The results showed that fiducial quantities with parameter 0.6 w 1 0.8 performed satisfactorily from small to large samples. Therefore, the fiducial tests could be recommended for practical applications. The recommended fiducial tests might be a competitive alternative to other available tests. Three real data sets were analyzed to illustrate the proposed methods were competitive or even better than other tests.

Keywords: difference; fiducial; matched-pairs design; non-inferiority.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Computer Simulation
  • Humans
  • Research Design*