ABSTRACT

Immediately after the FDA released the draft guidance on adaptive clinical trial design in February 2010 (FDA, 2010b) the Journal of Biopharmaceutical Statistics (JBS) published a special theme issue for adaptive clinical trial design (Vol 20, No. 6, 2010). This special theme issue consists of three special articles. The first special article provides a summary of the morning session of a spring conference (sponsored by the Basel Biometric Section of the Austro-Swiss Region of the International Biometric Society) on Perspectives on the Use of Adaptive Designs in Clinical Trials held at the Basel University, Basel, Switzerland on March 12, 2010 (Wang, 2010; Benda et al., 2010). The second special article is a collection of papers containing a leading article by the United States Pharmaceutical Research and Manufacturers of America (PhRMA) Working Group on adaptive designs followed by a number of discussion papers on the FDA draft guidance (Gallo et al., 2010). The third special article attempts to provide a better understanding of the FDA draft guidance from a practitioner’s point of view (Liu and Chi, 2010). This chapter will summarize some of the key points from the draft guidance and the experts. However, it should be noted that, as indicated in the draft guidance, the draft is not ready for implementation but for discussions and suggestions. Nevertheless, it reflects the FDA’s current thinking. Thus, this guidance should be viewed as regulatory recommendations rather than regulatory requirements.