EU DARWIN Project To Catalog Real-World Data Sources
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.
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Protection of IP and trade secrets and the need for clarity around issues such as the rules on access to data and the sharing of clinical trial data are seen as key issues in the European Commission’s plans for a European Health Data Space.
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.
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.