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Activity Number: 160
Type: Invited
Date/Time: Monday, August 10, 2015 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract #314405 View Presentation
Title: Advancing Safety Analyzes in Drug Development: Innovative Statistical Approaches and Real-World Examples---Phase 1 Through Post-Marketing
Author(s): Andrea Best*
Companies: AbbVie
Keywords: Safety Analyses ; Signal Detection ; Clinical Trial Safety
Abstract:

The last decade has seen numerous innovative statistical approaches to safety analysis, trial conduct and signal detection. This presentation will highlight some of the most current applications of these principles utilizing examples throughout the phases of drug development including less traditional applications of statistical methods applied to risk based monitoring of clinical trial sites. Examples will highlight how these statistical methods are applied to safety analyses including discussion of the Continual Reassessment Model, Univariate Analysis with Classification and Regression Tree Analysis along with application of Epidemiologic principles in the post-marketing safety setting.


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

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