On non-inferiority margin and statistical tests in active control trials.

Journal Article (Journal Article)

The problem of selecting a non-inferiority margin and the corresponding statistical test for non-inferiority in active control trials is considered. For selection of non-inferiority margin, the guideline by the International Conference on Harmonization (ICH) recommends that the non-inferiority margin should be chosen in such a way that if the non-inferiority of the test therapy to the active control agent is claimed, the test therapy is not only non-inferior to the active control agent, but also superior to the placebo. Furthermore, variability should be taken into account. Along this line, a method for selecting non-inferiority margins with some statistical justification is proposed. Statistical tests for non-inferiority designed in the situation where the non-inferiority margin is an unknown parameter are derived. An example concerning a cancer trail for testing non-inferiority with the primary study endpoint of the time to disease progression is presented to illustrate the proposed method.

Full Text

Duke Authors

Cited Authors

  • Chow, S-C; Shao, J

Published Date

  • April 15, 2006

Published In

Volume / Issue

  • 25 / 7

Start / End Page

  • 1101 - 1113

PubMed ID

  • 16345042

International Standard Serial Number (ISSN)

  • 0277-6715

Digital Object Identifier (DOI)

  • 10.1002/sim.2208


  • eng

Conference Location

  • England