Real world data (RWD) describe the experience of patients through data collected in surveys, registries, and more recently from sensors (“wearables”) or through their routine interactions with the healthcare system (electronic health records, claims data). They contain information on diagnoses, procedures, inpatient and outpatient episodes, laboratory and imaging examinations, prescriptions, costs, physical activity level (i.e., using sensors), or life quality (i.e., using registries or surveys).
Metadata characterize RWD and are crucial to improve data discoverability, create a deeper understanding of their meaning and achieve reliability and quality when using them to improve the evidence available for benefit-risk decisions. Overall, they contribute to supply patients with better medicines.
The European Medicine Agency (EMA) has released a draft practice guide for the stakeholders who want to make use of the Metadata Catalog of Real-World Data Sources to identify the correct sources for specific research questions. It is the first guide produced worldwide to focus on metadata to empower systematic integration of real-world evidence in medicines regulation.
The guide will replace the existing catalogue of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP). The public consultation is open until 16 November 2022, and it is expected to be released in late 2023.
RPN has successfully supported clients by generating innovative strategic solutions to optimize the drug development and is ready to provide prompt updates on the first ever guide for the use of real-world metadata.