A Constructive Critique of the Draft ICH E9 Addendum

• 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
• Author(s): Daniel Scharfstein*
• Companies: Johns Hopkins School of Hygiene & Public Health
• Keywords: Estimand; Sensitivity Analysis; Regulatory Approval; Treatment Strategy; Intent-to-Trear; Pain

Abstract

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.