Online Program

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Tuesday, September 24
Tue, Sep 24, 11:45 AM - 1:00 PM
Various Rooms
Roundtable Discussions

TL17: Experience Sharing in Defining Primary Estimand in Psychiatric Clinical Trials Following the Release of the Draft ICH E9(R1) Addendum (300860)

*Peiling Yang, FDA 

Keywords: estimand, ICH E9(R1), psychiatric clinical trials

Room: Madison B

After the release of the draft ICH E9(R1) addendum, Sponsors conducting psychiatric trials have been asked to refer to this draft guideline for the proposed primary estimand, as well as to provide the rationale for it and justify the suitability of the proposed primary analysis. The objective of this roundtable is to share experiences among and to solicit feedback from the roundtable participants.