ABSTRACT
In the past decade, it has been recognized that increasing spending on biomedical research has not resulted in an increase in the success rate of pharmaceutical and clinical development. This chapter not only introduces the concept of adaptive design but also reviews the relative advantages, limitations, feasibility, and acceptability of commonly considered adaptive designs in clinical development. Although the use of adaptive design methods in clinical trials can be traced back to late 1970, when the concept of adaptive randomization was introduced to increase the probability of success in clinical trials, there existed no universal agreement on and formal definition of adaptive trial design in the literature until 2005. Adaptive randomization design allows modification of randomization schedules based on varied and/or unequal probabilities of treatment assignment. The motivation behind the use of adaptive design methods includes the flexibility of being able to modify trial and statistical procedures and the possibility of shortening the development time of the compound.
