|
Abstract:
|
Both FDA and EMA released guidance for co-development of combination therapy with two or more novel compounds. The guidance provides a high-level description for the development of two or more new investigational drugs and describes the necessity of demonstrating the contribution of each component to the effect of the novel combination therapy. While it is well recognized it is critical to demonstrate the contribution of each individual drug to the combination, certain questions remain. For example, what level of evidence is needed, whether a rigorous testing procedure is necessary, how this demonstration of contribution of components can be optimized. In this roundtable discussion, statisticians from academia, FDA, and industries will exchange and share their thoughts and experience on this topic. For example, when is a randomized comparison between the combination and component(s) needed? What innovative design options are available other than the factorial design? What external data sources (e.g., real world data) can be used to establish the contribution of component? How do the disease settings impact on the approaches of demonstrating of contribution of component?
|
