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

Mathematics

Journal of Biometrics & Biostatistics

Author(s): Chow SC, Shao J

Abstract Share this page

Abstract 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. Copyright 2005 John Wiley & Sons, Ltd. This article was published in Stat Med and referenced in Journal of Biometrics & Biostatistics

Relevant Expert PPTs

Relevant Speaker PPTs

Recommended Conferences

Relevant Topics

Peer Reviewed Journals
 
Make the best use of Scientific Research and information from our 700 + peer reviewed, Open Access Journals
International Conferences 2017-18
 
Meet Inspiring Speakers and Experts at our 3000+ Global Annual Meetings

Contact Us

 
© 2008-2017 OMICS International - Open Access Publisher. Best viewed in Mozilla Firefox | Google Chrome | Above IE 7.0 version
adwords