Adaptive Design Working Group Dinner Session

Chair: Ginger Haynes, PhD

There are multiple challenges in the design of comparative effectiveness studies including selecting endpoints, comparator(s), and study population(s). These studies may be larger and longer than placebo-controlled Phase III trials, requiring substantial investment for the study sponsor. Additionally, limited comparative information may be available at the time of protocol development on which to base the decision on endpoints, comparator(s) and study population(s). The ISCTM Adaptive Design Working Group will discuss the issues associated with these decisions and explore the use of multiple adaptations within a single Phase IIIB/IV comparative effectiveness study in schizophrenia.