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Abstract Details

Activity Number: 100
Type: Invited
Date/Time: Monday, July 30, 2012 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract - #303897
Title: A Case Study for Selection of Margin and Statistical Analysis Method
Author(s): Bo Yang*+
Companies: Merck Research Laboratories
Address: 2015 Galloping Hill Rd, Kenilworth, NJ, 07920,
Keywords:
Abstract:

Recently, FDA issued a guidance about design and analysis of non-inferiority study. This guidance provides answers to many frequently encountered issues in the design of NI trials. However, questions remain that continue to challenge the design and analysis of well controlled and well powered NI clinical trials. In this talk, a case study for selection of non-inferiority margin and analysis method is presented to illustrate current statistical, clinical and regulatory issues and challenges.


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