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Activity Number:
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507
- Non-Inferiority, Biosimilarity and Related Topics
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Type:
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Contributed
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Date/Time:
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Wednesday, July 31, 2019 : 10:30 AM to 12:20 PM
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Sponsor:
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Biopharmaceutical Section
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Abstract #305319
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Presentation
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Title:
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Statistician’s Perspective of Meta-Analysis to Establish Non-Inferiority Margin for Phase 3 Study
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Author(s):
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Aparna Raychaudhuri* and Fanny Mitrani-Gold
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Companies:
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CSL Behring and GlaxoSmithKline
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Keywords:
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meta-analysis;
non-inferiority margin
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Abstract:
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Active-comparator, non-inferiority study designs are generally used in antibacterial drug development, due to ethical issues of using placebo treatment. To conduct a non-inferiority trial, an estimate of the treatment effect of the planned antimicrobial comparator must be obtained from historical trial data. This presentation describes the statistical methods and our experience of establishing a non-inferiority margin for a phase 3 clinical trial in uncomplicated urinary tract infection (uUTI). The Food and Drug Administration (FDA) updated the draft guidance for uUTI in 2018. This draft guidance presents the treatment difference (M1) of the pooled antibacterial group for the preferred primary efficacy endpoint of therapeutic response and subsequently recommends a noninferiority margin (M2) after preserving a portion of the active comparator treatment effect. We will present the meta-analysis included in the FDA draft guidance and discuss the inherent assumptions from a statistical perspective.
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Authors who are presenting talks have a * after their name.
