EMA - Article on RWE

19th July 2024

EMA - Article on Real-World Evidence (RWE) to support EU regulatory decision making: results from a pilot regulatory use cases

The article shows that studies using real-world data (RWD) can complement evidence from clinical trials and fill evidence gaps during different stages of a medicine's lifecycle. This review presents the experience resulting from the European Medicines Agency pilot to generate RWE to support evaluations by EU regulators and down-stream decision makers from September 2021 to February 2023. 

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