RWE Studies To Hit 100+ Per Year In Europe By 2025
The EU’s big data steering group has laid out some ambitious proposals for integrating real-world evidence into regulatory decision making, as well as plans for ongoing engagement on the use and analysis of RWE with industry and other stakeholders.
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A two-year pilot will explore the many potential benefits that the analysis of raw data can bring to the EU drug evaluation process. These range from faster patient access to medicines, companies facing fewer questions, and better definition of the target treatment population.
The latest meeting of the DARWIN EU advisory board heard about moves to increase the number of RWD sources that can be analyzed and to improve the efficiency of performing RWE studies.
A technical workshop is planned for later this year to identify common “use cases” for real-world evidence that are important to the European Medicines Agency, health technology assessment bodies and payers.