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Activity Number: 320 - The New ICH Guideline on Estimands: An Academic Perspective
Type: Invited
Date/Time: Tuesday, August 1, 2017 : 10:30 AM to 12:20 PM
Sponsor: ENAR
Abstract #322154 View Presentation
Title: The New ICH Guideline on Estimands: An Academic Perspective
Author(s): Estelle Russek-Cohen* and Susan Ellenberg* and Scott Emerson* and Eric Tchetgen Tchetgen* and T. Shun Sato*
Companies: Harvard University and U.S. Food and Drug Administration and University of Kyoto and University of Pennsylvania and University of Washington
Keywords: Estimands ; Sensitivity Analyses ; ICH ; Causal Inference ; Clinical Trials
Abstract:

The original ICH E9 Statistical Principals for Clinical Trials has impacted the clinical trial enterprise in many ways. Even though the motivation for the guideline was to provide for well conducted clinical trials for the purpose of submitting a drug or biologic to a regulatory agency, many in academia have relied on the principals outlined in the guidance. An addendum to E9 is being developed dealing with Estimands and Sensitivity Analyses. It will be available for public comment. An Estimand is the quantity that will be used to capture treatment benefit and it should be valid in spite of postrandomization events such as dropouts and protocol deviations. The focus of the addendum is laying out best practices in structuring estimand(s) of interest at the planning stage of a clinical trial and also planning for sensitivity analyses. This session will focus on training students and others in how to design studies with an estimand in focus and also talk about the analysis challenges, including potential research. The panel has experts in the design and analysis of clinical trials and methodologists with interest in causal inference.


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

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