Regulatory Perspectives of Adaptive Design Throughout Drug Developments
*Sue-Jane Wang, FDA 

Keywords: adaptive design; draft guidance

In light of the recently published US FDA draft guidance for industry on adaptive design clinical trials for drugs and biologics, the interests to pursue adaptive design seem increasing. The publication has also allowed us to take a fresh look of other designs including fixed designs, group sequential designs and a broader class of flexible designs. In this commentary, regulatory perspectives from review experiences will be shared. Typical case examples may be used to highlight the thought process of an adaptive design consideration in clinical development programs.