SESSION L

TITLE: Safety and Benefit-Risk Evaluation with Practical Visual Analytical Tools
SPEAKERS: Melvin Munsaka, AbbVie Inc and Jim Buchanan, Covilance LLC
MODERATOR: William Wang

Abstract:

Defining the scientific questions of interest in a clinical trial is crucial to align its design, conduct, analysis, and interpretation. With the recent release of the ICH E9(R1) guideline, regulatory agencies require statistical analyses to be aligned with the target estimand(s) which precisely describe the treatment effect(s) of interest that a clinical trial should address. For a given estimand, an aligned method of analysis, or estimator, should be implemented that is able to provide an estimate on which reliable interpretation can be based and which includes the handling of post-randomization events, missing data and sensitivity analyses. Many statistical analysis procedures are available for different types of data, although it is often unclear which estimands these imply. In this tutorial, we discuss how to identify and implement analyses approaches as well as sensitivity analyses that are aligned with a chosen estimand for different types of endpoints (continuous, binary, time-to-event, recurrent events) in longitudinal clinical trial settings. We illustrate the methods with real case studies and provide code examples to facilitate implementation in practice.

Instructors’ Biography:

Dr. Melvin S. Munsaka is currently Senior Director and Head of Safety Statistics at AbbVie. He has more than 25 years of industry experience. He is a member of the ASA Biopharmaceutical Safety Scientific Working Group, DIA Bayesian Scientific Working Group, and the PHUSE Safety Analytics Working Group

 

 

 

 

Dr. James Buchanan, president of Covilance LLC, has 30+ years of drug safety experience in the pharmaceutical industry. He is a co-lead of the ASA Biopharmaceutical Safety Working Group and the Interactive Safety Graphics taskforce that is developing novel, open-source, interactive graphical tools to evaluate drug safety issues.

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