Adaptive Design Studies: Operational and Regulatory Challenges
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*Lisa A Kammerman, AstraZeneca 

Keywords: adaptive design

This talk describes operational and regulatory challenges associated with two-stage seamless adaptive design studies. The focus is on studies that are intended to provide the primary evidence of efficacy to support the approval of a medical product. Seamless adaptive designs are often touted for their potential to shorten product development time. However, the benefit of speed must be balanced against the risks of implementation errors, which this talk will highlight. Further, the results coming from adaptive design studies can be difficult to interpret. I will use a case study, crofelemer tablets (NDA 202-292), to illustrate these principles and to provide recommendations for future adaptive design studies.