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What Question Are You Trying to Answer? The Use of Estimands, Potential Revisions to ICH E-9 and the Impact to Trial Design and Analysis
Session Chair(s)
Thomas J. Permutt, PhD
Associate Director for Statistical Science and Policy, OB, OTS, CDER
FDA, United States
This session will cover the proposed revision to ICH E9 that introduces estimands and their use in answering clinical trial questions, particularly in the case of missing data. Examples of interactions with regulators and the impact on protocols and analysis plans will be discussed.
Learning Objective : Identify the definitions and intended use of estimands.
Speaker(s)
Measuring Effectiveness of Treatment Regimens in Diabetes Clinical Trials
Fanny Ki Wong, PhD
AstraZeneca, United States
Director and Biometric Team Leader
New Treatment, New Question: Thinking Through the Logic of Estimands
Michael P O'Kelly, PhD, MA
QuintilesIMS, Ireland
Senior Director, Centre for Statistics in Drug Development, Innovation
Defining Treatment Effects
Thomas J. Permutt, PhD
FDA, United States
Associate Director for Statistical Science and Policy, OB, OTS, CDER
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