Sunday, Aug 4: 4:45 PM - 5:05 PM
Invited Paper Session
Oregon Convention Center
Information Bayesian methods have been proposed and are increasingly used in pediatric trials to implement extrapolation approaches that rely to a flexible degree on borrowing the study results in other populations, such as adults and older pediatric patients. This is because Bayesian methods offer a rigorous way to incorporate this prior information to reduce the burden of the efficacy studies in the target population. However, one of the main challenges in implementing such approaches is deciding the appropriate degree of borrowing in a particular situation. In this presentation I will discuss considerations for determining this degree of borrowing from the perspective of a regulator.
*This speech reflects the views of the author and should not be construed to represent FDA's views or policies.