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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 #304198 Presentation
Title: Implementation of Estimand Framework in Oncology Clinical Trials
Author(s): Kalyanee Appanna* and Bharani Dharan and Yuanbo Song and Ekkehard Glimm
Companies: Novartis Pharmaceutical Corporation and Novartis Pharmaceuticals and Novartis Pharmaceutical Corporation and Novartis Pharma AG
Keywords: Estimand; intercurrent event; analytic approach

The recently released ICH E9(R1) draft addendum presents a structural framework for the use of estimands in clinical development,aligning trial planning, design,conduct,analysis and interpretation. This promises to have a significant impact on the manner in which multi-disciplinary project teams will undertake drug development.In this presentation we will discuss two case studies based on:i)A randomized phase II study in patients with non-small cell lung cancer in the neoadjuvant setting,with the primary endpoint of major pathological response rate,which is defined as the percentage of subjects with ? 10% residual viable cancer cells detectable in the resected tumor after 6 weeks of treatment and ii)A randomized phase III study in patients with lung neuroendocrine tumors, with the primary endpoint of progression-free survival, defined as the time from the date of randomization to the date of the first documented progression or death due to any cause. In the 2 cases, we will discuss the estimand definitions for the primary endpoint, corresponding analytic approaches including the handling of intercurrent events and strengths and cautions regarding different estimand approaches.

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

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