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Activity Number: 114 - Applying the ICH E9(R1) Addendum: Practical Considerations in Choosing Estimands, Estimators, and Sensitivity Analyzes
Type: Topic Contributed
Date/Time: Monday, July 29, 2019 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract #304896 Presentation
Title: How Should We Select and Define Trial Estimands? – Examples Based on a Disease State
Author(s): Elena Polverejan*
Companies: Johnson & Johnson-Janssen R&D
Keywords: Estimand; Sensitivity analysis; ISCTM; Depression

The draft ICH E9(R1) Addendum on “Estimands and Sensitivity Analysis in Clinical Trials” proposed a framework for treatment effects to be more precisely specified, this way facilitating the discussions between sponsors and regulators. Regulatory agencies are adopting the estimand framework, increasing the number of requests on estimand selection. The Addendum also emphasized that “the construction of the estimand(s) in any given clinical trial is a multi-disciplinary undertaking including clinicians, statisticians and other disciplines involved in clinical trial design and conduct”. The Estimands and Missing Data Working Group of the International Society for CNS Clinical Trials and Methodology (ISCTM Estimand WG) consists of both clinicians and statisticians from FDA and Industry. This presentation will share the ISCTM Estimand WG experience of devising a structured process that could be used by clinical teams when planning a clinical trial according to the ICH E9(R1) guidance, with examples from Major Depressive Disorder.

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

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