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Activity Number: 277 - Estimand Framework and Its Impact on Drug Development in Oncology
Type: Topic Contributed
Date/Time: Tuesday, August 4, 2020 : 1:00 PM to 2:50 PM
Sponsor: Biopharmaceutical Section
Abstract #309906
Title: Impact of Estimand Framework on Oncology Drug Development
Author(s): Steven Sun* and Anja Schiel * and Kunthel By* and Catherine Njue* and Richard J. Cook*
Companies: Janssen and Norwegian Medicines Agency and FDA and Health Canada and ICH E9(R1) working group and University of Waterloo
Keywords: Estimand; oncology drug development; clinical trial design; treatment switching

The final R1 addendum to the ICH E9 guideline was released in December 2019 to introduce the estimand framework. This framework seeks to align clinical study objectives with design, conduct, and statistical analyses by requiring clarity and understanding of the quantity of scientific interest (the target of estimation or “estimand”). This session will feature panelists from academia, regulatory agencies and industry to discuss where pharmaceutical drug development stands in adopting the estimand framework and to share experiences in its implementation in oncology drug development. Oncology drug development often faces unique challenges such as complicated treatment regimens with multiple treatment phases and frequent treatment deviations with subsequent therapy before disease progression. Therapeutic knowledge and drug mechanism play a crucial role in determining the estimand of interest. Panelists will provide their perspectives to address these unique challenges in the actual implementation of the estimand framework and to illustrate how this framework can facilitate communication from industry to stakeholders, such as health authorities and HTA bodies.

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

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