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Thursday, September 13
Thu, Sep 13, 8:15 AM - 10:00 AM
Thurgood Marshall Ballroom
Plenary Session 1: Estimands in Clinical Trial: Industry and Regulatory Perspectives

Some thought on implementation of ICH E9(R1) (300803)

*Tom Permutt, FDA 

The proposed addendum to ICH E9 can be read in two ways. There is a new framework for talking about estimands, but is it about fitting present methods into the framework? Or is it about changing methods? Some of each. Where different methods are needed, there are challenging problems in estimating some desirable estimands, but there may also be desirable estimands that can be estimated easily and robustly.