All Times EDT
Keywords: cardiovascular, CNS, mortality, morbidity, estimand
For decades, group sequential design (GSD) has been quite successfully used for evaluation of new treatments in cardiovascular mortality or mobility trials. In recent years, there has been increasing use of GSD in central nervous system (CNS) trials where the endpoints are more of symptomatic or functional. As usual is the case, a clinical trial is intended to study multiple objectives, multiple doses or dose regimens, possibly different subject subpopulations. Several estimand features are targeted. In this talk, I will share some of regulatory experiences in use of GSD in clinical trials for cardiovascular, renal and CNS diseases. Topics to cover are validity of statistics and implementation of GSD.