ICH E9 R1 Addendum: Can We Deliver on the Promise?

• Activity Number: 114 - ICH E9 R1 Addendum: Can We Deliver on the Promise?
• Type: Invited
• Date/Time: Monday, August 3, 2020 : 1:00 PM to 2:50 PM
• Sponsor: Council of Chapters
• Author(s): Craig Mallinckrodt* and Steve Ruberg* and Elena Polverejan* and Scott Emerson* and H. M. James Hung*
• Companies: Biogen and Analytix Thinking, LLC and Janssen Pharmaceuticals and University of Washington and CDER at FDA
• Keywords: estimands; sensitivity analysis; clinical trials; intercurrent events; missing data; treatment effect

Abstract

This invited panel will focus on the upcoming final ICH-E9(R1) addendum on estimands and sensitivity analysis in clinical trials. This addendum will set a new standard for how to describe a treatment and its effect(s) on patients. The session will start by having all panelists deliver a 15-minute presentation on a topic of their choosing in response to one or more of the following questions:

In view of the upcoming final guidance on the ICH-E9(R1) Addendum: What can we do that has not been done? Has not been done enough? Has not been done well?

A structured Q&A will be prepared to follow the presentations. However, audience questions and engagement will be encouraged and given priority over the prepared questions.