On June 14, 2022, the following update was posted on the EU PAS, News section.
A list of metadata describing real-world data sources and studies has been published on the EMA website, to help pharmaceutical companies and researchers to identify and use such data when investigating the use, safety and effectiveness of medicines.
Real-world data are observational data stored in repositories such electronic health records and disease registries. Making use of these data sources can improve the evidence available to support benefit-risk decisions and facilitate getting better medicines to patients.
This metadata list will feed into two future EU catalogues on real-world data sources and studies:
- The catalogue of data sources will cover information on real-world databases, replacing the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) catalogue
- The catalogue of studies will cover studies performed on the data sources, enhancing and replacing the European Union electronic register of post-authorisation studies (EU PAS Register)
Setting up a catalogue of data sources and enhancing the catalogue of studies aims to improve transparency with regard to observational studies, enhanced discoverability of studies and data sources, and contribute to increasing the ability to judge the evidentiary value of studies when used to investigate the use, safety and effectiveness of medicinal products. It also helps regulators, researchers and pharmaceutical companies identify studies and data sources suitable to address research questions, based on the so-called ‘FAIR’ (findable, accessible, interoperable and reusable) data principles.