Real-World Data: EMA´s Good Practice Guide

The European Medicines Agency (EMA) has published for public consultation a Good Practice Guide for the use of the Metadata Catalogue of Real-World-Data Sources. According to the agency it is the first guide worldwide to focus on metadata to empower systematic integration of Real-World-Evidence (RWE) in medicines regulation. The guide provides recommendations on how to use the real-world metadata catalogue that is currently being built and in late 2023 will replace the existing catalogue of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP). The guide will help to identify suitable RWD sources and describes the metadata elements that will be used.

Metadata and Real-World Data

Real-world data (RWD) are observational data stored in repositories such as electronic health records (eHRs) and disease registries. Metadata characterise RWD and are essential to improve data discoverability, create a clearer understanding of their meaning and achieve greater reliability and quality when using them to improve the evidence available for benefit-risk decisions.

The assessment of the suitability of data sources should therefore differentiate between two aspects of data quality:

  • Quality in relation to the reliability of the primary data (e.g. the detection and correction of errors, missing data and implausible values, verification and validation of formats, codes, values, time components and underlying calculations, unique identification numbers for each person, documentation of standardised processes leading to entry and exit of person).
  • Quality in relation to the relevance of the data source to provide adequate and valid evidence informing a specific research question following the application of appropriate epidemiological and statistical techniques.

Registering a Data Source & Maintenance of Information

A data holder would be able to request to register on a voluntary basis a data source in the Data source catalogue via the dedicated webform (will be made available in the second half of 2023). In addition, the agency is proactively contacting data holders requesting the addition of the metadata information in the catalogue, looking to current data sources registered in ENCePP Resources Database. The update of information is expected to be run on a yearly basis or more often for particular data sources if found necessary. The data holder will be provided with the technical means to update the information provided directly via the dedicated webform.

Comments should be provided to the EMA by 16 November 2022. More information is available in EMA´s Good Practice Guide for the use of the Metadata Catalogue of Real-World Data Sources.

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