Real-world evidence (RWE) is becoming an indispensable tool for pharma companies. The availability of digital health tools, electronic health records (EHRs) and advances in data analytics have facilitated the large-scale collection of real-world data (RWD), enabling a wealth of insights into patient outcomes and clinical effectiveness and safety of medicines beyond clinical trials. As testament of RWEs growing importance, regulators including European Medicines Agency (EMA) and Health Technology Assessment (HTA) agencies are increasingly recognising the role of RWE to support drug approval, post-market surveillance and reimbursement. Expanding its role further, particularly in the field of oncology, holds the promise of accelerated drug development, reduced healthcare costs and improved health outcomes for patients across Europe. 

However, despite RWE’s unquestionable benefits, challenges need to be addressed before its potential is fully realised, including data quality, access, privacy and interoperability. Of particular concern is a lack of standardisation of RWE across countries. Pharma companies typically conduct clinical research on a global basis; however, regulators and HTAs have preferred local data to inform their decision making, adding to cost, duplication and approval delays for drug makers. The development of global standards for RWE would facilitate the exchange and transportability of data across borders, ensuring that RWE is accessible and applicable worldwide and providing the tools to understand and compare local treatment pathways.  How could the European health information infrastructure be improved, and how can we open the door to more effective evidence generation globally?

This Financial Times webinar, in partnership with Flatiron Health, will bring together global biopharma companies, health regulators, health technology assessors, and other industry experts to explore the evolving landscape for real-world evidence (RWE) in Europe, and how the regional and global evidence base can be improved and harmonised to revolutionise healthcare decision-making, drug development and patient care.

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