Better Decision-Making for Better Outcomes: A Call to Action on Harnessing the Power of Real-World Evidence
This Call to Action, co-signed by Cancer Patients Europe, two MEPs (Stelios Kympouropoulos and Tomislav Sokol), and leading European academic and clinical researchers, addresses the critical role of Real-World Evidence (RWE) in informing health decision-making. Using case studies from influenza vaccination, rare diseases, and oncology, the document demonstrates how RWE complements randomised clinical trial data by enabling holistic understanding of medicine effectiveness, impact, and safety in heterogeneous populations. The signatories issue four policy demands to EU policymakers, regulators, and payers: appropriate consideration of RWE in approving and assessing medicines, enhanced access to RWE for decision-making, standardisation of RWD and RWE definitions with EU-wide interoperability, and promotion of best practice exchange through multi-stakeholder collaboration.