Conference Program

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All Times EDT

Thursday, September 22
Thu, Sep 22, 9:45 AM - 10:30 AM
White Oak
Poster Session

Estimands in Oncology ASA Scientific Working Group (303657)

Evgeny Degtyarev, Novartis 
Stefan Englert, AbbVie Deutschland GmbH & Co KG 
Racheal Lawrance, Adelphi Values 
Yi Liu, Nektar Therapeutics 
Francois Mercier, Roche 
Kaspar Rufibach, Roche 
*Jonathan Siegel, Bayer US 
Yufei Wang, GlaxoSmithKline 
Hans-Jochen Weber, Novartis Oncology Schweiz AG 
Jiawei Wei, Novartis Institutes for Biomedical Research Co. 

With the release of the initial draft ICH E9 (R1) addendum in 2017, it was anticipated that the estimand framework will have a major impact on formulation of clinical trial objectives, trial design, sample size, conduct, data collection, and analysis. For time-to-event endpoints which are prevalent in oncology (such as progression-free or overall survival), many open questions concerning estimand definition, data collection, analysis methodology, and interpretation remained. Thus, in February 2018, a cross-industry international working group (www.oncoestimand.org) was founded bringing together statisticians from industry, regulators, and academia to share experience and ensure common understanding and consistent definitions for key estimands, strategies for intercurrent events, and corresponding analysis in oncology. In November 2018, the working group was established as a European special interest group ‘Estimands in oncology’, sponsored by PSI and EFSPI, and became an ASA biopharmaceutical section scientific working group in June 2019. As of 30 March 2022, the working group has 85 members representing 42 companies / institutions / universities and regularly interacts with eight Health Authorities globally. Currently the working group operates within 9 agile task forces to review and provide answers to key clinical trial issues in line with the estimand framework. The spirit of the working group has been very inclusive from the beginning, new members can join and start to contribute at any time. The poster will describe the history, scope, organizational structure, and collaborations of the ASA scientific working group ‘Estimands in oncology’. Details will be given on the objectives of each task force as well as a summary of the achievements made so far.