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.
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Key Dates
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April 30 - May 22, 2013
Invited Abstract Submission Open -
June 4, 2013
Online Registration Opens -
August 9 - August 23, 2013
Invited Abstract Editing -
August 23, 2013
Short Course materials due from Instructors -
August 26, 2013
Housing Deadline -
September 9, 2013
Cancellation Deadline and Registration Closes @ 11:59 pm EDT -
September 16 - September 18, 2013
Marriott Wardman Park, Washington, DC