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Activity Number: 409 - Estimands in Oncology: Papers from an Industry Working Group
Type: Topic-Contributed
Date/Time: Thursday, August 12, 2021 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract #317332
Title: Use of Estimand Framework in Hematology Oncology Trials: Practical Implementation
Author(s): Steven C Sun* and Satrajit Roychoudhury
Companies: Janssen and Pfizer Inc.
Keywords: Estimand; hematology clinical trials; Intercurrent events; ICH E9 addendum

The estimand framework included in the addendum to the ICH E9 guideline facilitates discussions to ensure alignment between the key question of interest, the analysis, and interpretation. Therapeutic knowledge and drug mechanism play a crucial role in determining the strategy and defining the estimand for clinical trial designs. Clinical trials in patients with hematological malignancies often present unique challenges for trial design due to complexity of treatment options and existence of potential curative but highly risky procedures, e.g. stem cell transplant or treatment sequence across different phases (induction, consolidation, maintenance). In this talk, we illustrate how to apply the estimand framework in hematological clinical trials and how the estimand framework can address potential difficulties in trial result interpretation.

This presentation is a result of a cross-industry collaboration to connect the ICH E9 addendum concepts to applications. Real phase 3 trials will be used to consider common challenges to illustrate different scientific questions and the consequences of the estimand choice for trial design, data collection, analysis, and interpretation.

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

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