PSI EIWG Webinar: Estimands in Oncology - How and Why
Date: Tuesday 1st & Wednesday 2nd June 2021
Time: 1st 15:00-16:30 BST | 2nd 09:00-10:30 BST
Speakers: Kaspar Rufibach (Roche), Stefan Englert (AbbVie), Giovanna Andreaola, MD (Novartis), Paul Bycott (Pfizer), Feng Liu (AstraZeneca), Jonathan Siegel (Bayer), Sammi Tang (Servier) and Jiawei Wei (Novartis).
Hosted by the Estimands Implementation Working Group (EIWG) and PSI on behalf of EFSPI and EFPIA.
Who is this event intended for? Clinicians, Investigators, Regulatory Experts, Medical Writers, Ethics Committees, Statisticians.
What is the benefit of attending? Through a case study you will understand the benefits of using the estimand framework to describe the diversity of patient journeys addressing the right questions in clinical trials.
You can now register for this event. This event is free of charge to both Members and Non Members of PSI.
Please note: this event takes place on both the 1st & 2nd June, but will entail exactly the same content. The sessions will run in order to accommodate for different timezones, so please note that places are limited for each session.
To register for the 1st June session, please click here.
To register for the 2nd June session, please click here.
A year on after the final ICH E9 estimands addendum was published, we bring estimands to life. Members of the Estimands in Oncology special interest group will describe 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.
You will be guided through a case study 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 (increased dropout rate and crossover therapy) that occurred in the trial and 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 as follows:
• Recognize the benefits of following the estimand framework (ICH E9 (R1) addendum) in the context of a clinical trial, in order to:
o have a common language to describe the diversity of patient journeys
o address the right question in clinical trials
• Be able to construct an estimand, including identification of relevant intercurrent events and application of relevant strategies to address them
• Gain insights from a cross-industry international working group on estimands in oncology.
Speaker details will be announced shortly.