ABSTRACT
As pointed out in Chapter 2, the United States Food and Drug Administration (FDA) kicked off the Critical Path Initiative in the early 2000s to assist the sponsors to identify possible causes of the scientiŒc challenges underlying the medical product pipeline problems. The Critical Path Opportunities List released by the FDA on March 16, 2006, identiŒed (1) better evaluation tools and (2) streamlining clinical trials as the top two topic areas to bridge the gap between the quick pace of new biomedical discoveries and the slower pace at which those discoveries are currently developed into therapies. This has led to the consideration of the use of adaptive design methods in clinical development and the focus of translational science/research, which attempt not only to identify the best clinical beneŒt of a drug product under investigation but also to increase the probability of success. Statistical methods for the use of adaptive trial designs in clinical development can be found in Chow and Chang (2006), Chang (2007), Pong and Chow (2010). In this chapter, we will focus on statistical methods that are commonly employed in translational science/research.
