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.