Weighting the Benefits & Risks: The Science and Methods of Benefit-Risk Assessment in Drug Development

Course Aim
Benefit-risk assessment is now a fundamental science for understanding and evaluating the development, approval, and continued marketing of drugs and medical devices. This course is aimed at introducing attendees to core concepts and tools of both the science and practice of benefit-risk assessment.

Requisites Statement
This is an introductory to mid-level course designed to acquaint attendees with the current state of the art in the use of benefit-risk assessment methods and tools. There are no prerequisites for this course.

Educational Objectives
--Develop an understanding of current regulatory policies regarding the use of structured and quantitative benefit-risk assessment including role for preference studies
--Develop an understanding of methods for structured and quantitative benefit-risk assessment
--Develop an understanding of how to successfully structure and present benefit-risk information for drug development decision-making and regulatory interactions, including the use of visual tools
--Develop an understanding of how pharmacoepidemiology and benefit-risk assessment intersects with preference methods

Syllabus Outline
Alicia Gilsenan, PhD, FISPE, presenting on behalf of Tarek A. Hammad, MD, PhD, MSc, MS, FISPE
This presentation will provide attendees with an overview of ICH expectations, FDA guidance and analytical considerations for the development and presentation of benefit-risk information in new drug applications
Juhaeri Juhaeri, PhD
Juhaeri Juhaeri will provide attendees with an overview of leading structured methods (e.g., MCDA, SMAA) for the development and presentation of benefit-risk assessment information
Christine Poulos, PhD
Christine Poulos will provide attendees with an overview of leading methods (e.g., discrete choice, direct elicitation, threshold technique) for the elicitation, analysis and presentation of patient preference information
Bennett Levitan, MD, PhD
Bennett Levitan will provide a conceptual overview and practical examples of integrating patient preference information with clinical data to inform structured and quantitative benefit-risk assessment
Alicia Gilsenan, PhD, FISPE
Alicia Gilsenan will moderate the session