The Growing Role Of Real-World Evidence

Real-World Evidence has moved well beyond its supporting role. Regulators at the EMA and FDA, alongside HTA bodies including NICE, HAS, and G-BA, are now treating RWE as a core input in their decision-making processes. For market access teams, that shift carries real consequences for how evidence strategies are built and what agencies expect to see.

If you are navigating Joint Clinical Assessments in Europe, you already know that the pressure to address comparators, patient populations, and PICOs with credible real-world data has intensified. Gaps that were once tolerated are now liabilities. Oncology provides the clearest example of where this is heading: integrated cancer registries and linked claims data across Europe are setting a new standard for longitudinal evidence that other therapeutic areas will be measured against.

In the U.S., large-scale EHR databases are enabling the kind of population-level insights that support both regulatory submissions and payer conversations. But data volume alone does not build credibility. Completeness, accuracy, and reproducibility remain the pillars agencies look for when evaluating whether RWE is fit for purpose.

This session brings together experts in integrated evidence planning and real-world evidence strategy to help you understand where the expectations are heading and how to stay ahead of them. Watch the discussion below to learn more before your next submission.