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Tuesday, June 20 • 4:00pm - 5:15pm
#285: 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

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Component Type: Session
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

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 Objectives

Identify the definitions and intended use of estimands.


Thomas J. Permutt, PhD


Measuring Effectiveness of Treatment Regimens in Diabetes Clinical Trials
Fanny Ki Wong, PhD

New Treatment, New Question: Thinking Through the Logic of Estimands
Michael P O'Kelly, Esq, PhD, MA

Defining Treatment Effects
Thomas J. Permutt, PhD

avatar for Michael O'Kelly

Michael O'Kelly

Senior Director, Centre for Statistics in Drug Development, Innovation, QuintilesIMS
Michael O’Kelly has published on many subjects related to clinical trials. He is co-author of the book "Clinical trials with missing data: a guide for practitioners", and co-ordinates the New Tools group of the DIA Scientific Working Group for Missing Data. He co-authored "Best... Read More →

Thomas Permutt

Director, Division of Biometrics II, Office of Biostatistics, OTS, CDER, FDA
Tom Permutt supervises the statisticians at FDA working on analgesic, pulmonary, and endocrine drugs. He was among the first to apply methods of causal inference to questions in biostatistics. He has been interested in the missing data problem since 1975, when he spent a summer a... Read More →
avatar for Fanny Ki Wong

Fanny Ki Wong

Director and Biometric Team Leader, AstraZeneca
Fanny Ki Wong is a Biometric Team Leader in diabetes and metabolic therapeutic areas at AstraZeneca. She has extensive working experience in clinical development in pharmaceutical industry.

Tuesday June 20, 2017 4:00pm - 5:15pm
S405a McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616