Utilizing External Data in Practice

Kert Viele Speaker
Berry Consultants
 
Thursday, Aug 7: 9:35 AM - 9:55 AM
Topic-Contributed Paper Session 
Music City Center 
In this talk we will discuss the assumptions required for external data to improve inferences in clinical trials, and how different methods produce different ranges and magnitudes of benefit and risk. We will illustrate these assumptions through completed clinical trials that have resulted in regulatory approvals.