The Application of Improved Fallback Procedure to Testing Noninferiority and Superiority for Multiple Endpoints

• Activity Number: 500
• Type: Contributed
• Date/Time: Wednesday, August 6, 2014 : 10:30 AM to 12:20 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Huiling Li*+ and Yong Wang and Kaifeng Lu
• Companies: Forest Research Institute and Forest Research Institute and Forest Research Institute
• Keywords: Closed testing ; Fallback procedure ; Multiple comparisons ; Non-inferiority ; Superiority

Abstract

The fixed sequence testing procedure imposes too many illogical constraints on the multiple testing problems of superiority and noninferiority in the presence of multiple endpoints (Hung et al., 2009 and 2010). The application of Fallback procedure alleviates the restrictions on the order of the hypotheses and provides an alternative to resolve the illogical problems (Westfall, 2011). We extend the method via the improved alpha exhaustive Fallback procedure to make the test more powerful. We first develop the stepwise testing procedure by constructing the improved Fallback procedure as a closed testing procedure while testing both superiority and non-inferiority for the same endpoint at the same nominal alpha level. The resulting procedure controls the familywise error rate (FWER) in the strong sense by construction. We then compare the procedure to other multiplicity adjustment methods. Examples are provided to illustrate the properties of the method.