Abstract Details
Activity Number:
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56
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Type:
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Invited
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Date/Time:
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Sunday, August 9, 2015 : 4:00 PM to 5:50 PM
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Sponsor:
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CHANCE
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Abstract #314421
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Title:
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Statistical Considerations for Antibacterial Drugs Targeting Unmet Medical Needs
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Author(s):
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Daniel Rubin*
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Companies:
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FDA
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Keywords:
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Abstract:
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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.
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Authors who are presenting talks have a * after their name.
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