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
Language
- eng
Conference Location
- England