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Activity Number: 459 - Rethinking Intercurrent Events and Estimators Within the ICH E9(R1) Estimand Framework
Type: Topic Contributed
Date/Time: Wednesday, July 31, 2019 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract #307091 Presentation
Title: A Constructive Critique of the Draft ICH E9 Addendum
Author(s): Daniel Scharfstein*
Companies: Johns Hopkins School of Hygiene & Public Health
Keywords: Estimand; Sensitivity Analysis; Regulatory Approval; Treatment Strategy; Intent-to-Trear; Pain

In this talk, I will review key elements of the proposed ICH E9 Addendum, present a constructive critique and provide recommendations of how it can be improved. To highlight ideas, I present a case study involving a confirmatory trial for a chronic pain medication.

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

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