IH06 - Navigating JCA: Strategies for generating comparative clinical evidence and the use of RWE

The EU’s Joint Clinical Assessment (JCA) introduces rigorous requirements for comparative clinical evidence across multiple PICOs, creating challenges for manufacturers in meeting diverse standards while ensuring regulatory compliance. This session provides an overview of JCA and explores practical strategies to align evidence generation with JCA guidelines, including indirect comparisons, network meta-analyses, and advanced methods. The session also addresses leveraging Real-World Evidence (RWE), with approaches such as External Control Arms and Target Trial Emulation, to address data gaps and demonstrate relative efficacy and safety of assets.