Title: Estimands How and Why - A Real Life Case Study in Oncology
Date and Time: Sep 28th 2021, 10am - 11:30am EST
Registration: https://diaglobal.zoom.us/webinar/register/WN_7KtHC7qtRRG78aJbZP9slg
The DIA Statistics and Data Science Community is pleased to announce a new webinar on Estimands on Sep 28th 2021, 10am - 11:30am EST.
The Estimands How and Why - A Real Life Case Study in Oncology Webinar will be presented by members of the Estimands in Oncolocy Special Interest Group:
Kaspar Rufibach (Roche), Stefan Englert (AbbVie), Paul Bycott (Pfizer), Feng Liu (Intercept), Jonathan Siegel (Bayer), Sammi Tang (Servier) and Jiawei Wei (Novartis).
Panelists will be:
Lei Nie and Donna Przepiorka from FDA, Catherine Njue from Health Canada and Frank Bretz from Novartis.
We do hope you can join us for this event.
Registration: https://diaglobal.zoom.us/webinar/register/WN_7KtHC7qtRRG78aJbZP9slg
Description of the webinar:
The aim of estimand framework (the ICH E9 R1 guidance) is to increase the dialogue between functional areas working on proper alignment of trial objectives formulation, design, conduct, statistical analyses, and conclusions.
This webinar is an opportunity to learn about the estimand framework. You will be guided through a case study (CheckMate 037) and interactively deepen the knowledge to gain hands-on experience in developing estimands. You will be introduced to the background and disease context of the case study, the concept of an estimand, and important clinical events that occurred in the trial and potentially affected interpretation of the results. Using non-technical language and clear graphical presentation of the concepts, you will experience how the estimand framework provides a common language to describe the diversity of patient journeys and why it is important to address the right question in clinical trials.
The targeted learning outcomes are to 1) recognize the benefits of following the estimand framework (ICH E9 (R1) addendum) in the context of clinical trial setting, in order to have a common language to describe the diversity of patient journeys and address the right question in clinical trials; 2) be able to construct an estimand, including identification of relevant intercurrent events and application of relevant strategies to address them; and 3) gain insights from a cross-industry international working group on estimands in oncology.
The talk was previously presented in the European region and received overwhelmingly positive feedback which motivated us to bring this professional development opportunity to members of the DIA. The target audience includes Clinicians, Investigators, Regulatory Experts, Medical Writers, Ethics Committees, and Statisticians. You don’t need to have prior knowledge in oncology or of estimands.
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https://diaglobal.zoom.us/webinar/register/WN_7KtHC7qtRRG78aJbZP9slg
https://diaglobal.zoom.us/webinar/register/WN_7KtHC7qtRRG78aJbZP9slg