All Times EDT
Keywords: estimand, intercurrent event
Sequential parallel comparison designs (SPCDs) initially proposed in FAVA et al (2003) and later increasingly evolved in literature have received a great deal of attention in regulatory applications, especially major depressive disorder trials. Attractiveness of SPCD is not of surprise. As the concept of estimand framework is stipulated in ICH E9 (R1), many innovative designs are incorporating this concept in discussion at the stage of using such designs. SPCD is no exception. This talk is intended to share my perspective on the related issues with use of SPCD. The following subjects are to be covered: 1. What should the summary measure of treatment effect? 2. Handling of intercurrent events 3. Assumptions underlying the statistical analyses.