New Trends in Medical Device Trials: From Basket to Umbrella – Implementing Learnings From Pharma Trials

9:30 AM - 9:55 AM


Regulatory requirements for more classes of medical devices to demonstrate clinical benefit throughout the lifecycle of the medical device increases the need for more innovative clinical study designs. Join me as I discuss different medical devices and how we applied lessons learned from basket and umbrella trial designs in oncology to diagnostic accuracy vs. clinical utility.