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Activity Number:
370 - Biopharmaceutical Section P.M. Roundtable Discussion (Added Fee)
Type: Roundtables
Date/Time: Tuesday, July 31, 2018 : 12:30 PM to 1:50 PM
Sponsor: Biopharmaceutical Section
Abstract #329260
Title: Uncertainty vs. Ambiguity in Structured Benefit-Risk (BR) Assessment Decisions
Author(s): Shahrul Mt-Isa*
Companies: Merck
Keywords: benefit-risk; uncertainty; decision-making

The assessment of BR balance is key to the decision making process in drug development life cycle. Many argue that marketing authorizations of these products are often based on "average" BR estimates; with statistical uncertainties, and sensitivity analyses informing these decisions. Recent advances in regulatory sciences also recognize the importance to incorporate patient preference information to make BR balance more patient-relevant. Needless to say, the uncertainty in preferences has been debated continuously. With increasing calls to integrate multiple endpoints for a more holistic BR assessment, the total uncertainty would grow due to propagation of uncertainties from various parameters. Making decisions under uncertainty is challenging; and so previous experience and other linked decisions often come into play. Which uncertainties matter and which only introduce ambiguity?

We will outline this controversial topic of near-heuristic decision making to gain views and insights of participants. We will uncover the decision thought processes, discuss where and whence uncertainty becomes ambiguity, and aim to set a foundation to lead the future of BR assessment with statistics.

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

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