Composite Hierarchical Endpoints: FDA Center for Devices and Radiological Health (CDRH) Office of Cardiovascular Devices Perspective

There are significant challenges for designing a cardiovascular device trial appropriate for FDA regulatory approval. Some of these issues are more specific to device trials as opposed to drug trials. The lecturer will review some of the current FDA Center for Devices and Radiological Health (CDRH) thinking on this topic and highlight considerations pertinent to the use of hierarchical composite enpoints and innovative trial designs in this setting.