TL7: Adaptive Designs in Medical Device Studies
*Jie Zhou, FDA 

Keywords: adaptive design, operational bias, medical device

Clinical studies with adaptive designs have been gaining attention from the medical device industry. The flexibility of these designs makes them quite popular. However, the challenges associated with these designs include unfamiliarity of the relevant statistical methodologies, the cost of extensive upfront planning, the operational/logistical issues involved and the acceptance of regulatory authorities. Please come and discuss the theoretical and practical issues you faced in adaptive designs and share some examples with your colleagues.