TL8: Adaptive design in medical device trials
*Peter Lam, Boston Scientific  Xiting (Cindy) Yang, FDA/CDRH 

Keywords: adaptive design, medical devices

The discussion will focus on the essentials of adaptive trial design for the therapeutic medical devices. Various aspects of adaptive trials, such as simulation, trial conduct, role of DMC, firewall, and scientific ways to maintain the trial integrity will be shared and discussed.