Statistical Inference Issues in Non-inferiority Methodology
*H.M. James Hung, FDA  Robert O'Neill, FDA  Sue-Jane Wang, FDA 

Keywords: fixed margin, synthesis test, multiple endpoints

For non-inferiority analysis, fixed margin method and synthesis test method are two widely discussed methods in recent literature. This presentation will highlight a major difference in statistical inference paradigm and convertibility between the two methods. Another topic to discuss is testing for superiority and non-inferiority in the situation that at least one secondary endpoint will be formally tested after the study reaches conclusion, superiority or non-inferiority, on the primary endpoint.