Adapting for the real world

Two years after launching a pilot program for its adaptive pathways initiative, EMA says work remains to develop better strategies for using real-world evidence to validate conditional approvals and to increase patient and payer involvement. The initiative could benefit from two Innovative Medicines Initiative projects that seek to develop methods and tools for collecting and interpreting real-world data, particularly in an adaptive licensing setting.

EMA launched the adaptive pathways program in 2014 to allow companies to market new products for limited populations based on promising but early data, followed by iterative approvals for additional populations based on postmarket trials and real-world data...