Moderator: Judith Anzures-Cabrera (Roche).
Presenters: Nikhil Kamath (Roche), Sue McKendrick (Thermo Fisher Scientific), Antonia Morga (Astellas), David Wright (AstraZeneca)
This is the fourth in the series of webinars from The Estimands Academy for Trial Teams. The estimand framework (ICH E9 (R1)) is applied to a case study in heart failure from the perspective of multiple stakeholders. Topics covered will include using different strategies for handling intercurrent events to construct estimands for different stakeholder questions of interest. The estimands bring transparency in the treatment effects we will estimate from the protocol through to product labels.
The targeted learning 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.
Target audience (no prior knowledge of estimands required): Clinicians, Regulators, Investigators, Academics, members of Ethics Committees, Health technology assessors, Statisticians.