PSI EIWG Webinar: Proposing Estimands from Different Perspectives
Date: Thursday 30th March 2023
Time: 14:00-15:30 BST | 15:00-16:30 CEST | 09:00-10:30 EST
Speakers: Judith Anzures-Cabrera (Roche), Nikhil Kamath (Roche), Sue McKendrick (PPD), Antonia Morga (Astellas), and David Wright (AstraZeneca).
Who is this event intended for? Clinicians, Regulators, Investigators, Academics, members of Ethics Committees, Statisticians and health technology assessors.
What is the benefit of attending? Attendees will have the opportunity to hear the perspectives of a variety of stakeholders in determining estimands, in turn understanding more about challenges and possible solutions when applying the framework to a challenging realistic setting.
Registration for this webinar is free to both Members of PSI and Non-Members.
Please click here to register.
This is the fourth in the series* of webinars from The Estimands Academy for Trial Teams. We will build on the concepts and case studies previously discussed, recognizing the benefits of following the estimand framework (ICH E9 (R1)). A case study in heart failure will be presented from the perspective of multiple stakeholders. Topics covered will include constructing estimands for different stakeholder questions of interest including how to develop transparent estimands for product labels.
The target outcomes are as follows:
• To apply the estimand framework to a challenging realistic setting
• To appreciate the different stakeholder views when determining estimands
• To understand the relative merits of different strategies for intercurrent events
• Understanding implementation challenges and possible solutions
To view the flyer for this event, please click here.
Judith Anzures-Cabrera is a data scientist at Roche. She is part of the Estimands Implementation Working Group where she leads the Training sub-team.
Nikhil Kamath is Group Medical Director and Global Development Leader within Global Product Development Immunology, Infectious Disease, and Ophthalmology at Roche.
Antonia Morga is a Global Health Economics and Outcome Research Director. She co-leads the EIWG team on HTAs and RWE studies and is part of EFPIA HTA Working Group.
David Wright is Head of Statistical Innovation at AstraZeneca, previously worked for the MHRA and led the revision of the CHMP guideline on missing data in confirmatory clinical trials.
Sue McKendrick is a Statistical Science Director leading the cross-functional Estimand Working Group at PPD and is also a member of the EIWG training subteam.