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Activity Number: 56
Type: Invited
Date/Time: Sunday, August 9, 2015 : 4:00 PM to 5:50 PM
Sponsor: CHANCE
Abstract #314421
Title: Statistical Considerations for Antibacterial Drugs Targeting Unmet Medical Needs
Author(s): Daniel Rubin*
Companies: FDA
Keywords:
Abstract:

This talk will discuss several statistical considerations that should be addressed when evaluating a new antibacterial intervention for the treatment of patients with limited therapeutic options. These include the choice between non-inferiority or superiority hypotheses, whether to use a randomized or external control group, the selection of an appropriate efficacy endpoint, and whether patients with infections at different body sites should be included in the same study.


Authors who are presenting talks have a * after their name.

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