ABSTRACT

There have been experiences indicating potential insufficiency of conventional nonadaptive fixed designs for clinical trials; in particular, some argue that the trial design should be expected to answer many study questions and not just those defined by the primary study objective. Subsequently, the level of difficulty in conducting a trial to address several study questions increases significantly. As a result, adaptive design is viewed as one alternative trial

design that not only can address several study questions but also save the time and costs necessary for drug development. This is the subject of this chapter.