Statistical Challenges with Emerging Adaptive Designs of Cardiovascular Device Studies: A Case Study and Beyond
*Yun-ling Xu, FDA  Ying Yang, FDA  Yu Zhao, FDA 

Keywords: Emerging adaptive design, PMA, Statistical challenge

On the changing landscape in cardiovascular device development, new adaptive designs are emerging to meet the advancement in technology and regulation. Within the context of using the result to support a pre-market application (PMA), challenging statistical issues related to emerging adaptive designs, including operating characteristics and practical implementation will be discussed with a case study.