Executive Summary
EU regulators have developed a draft good practice guide explaining how stakeholders can make use of the Metadata Catalog of RWD Sources, which is expected to be released in late 2023, to identify appropriate sources for specific research questions.
Source: ShutterstockIDENTIFICATION OF APPROPRIATE RWD SOURCES IS BECOMING INCREASINGLY IMPORTANT FOR REGULATORY DECISION MAKING
Regulators in the EU have issued draft recommendations explaining how drug companies and other stakeholders can identify suitable real-world data sources for studies, and what metadata elements they should consider for this purpose.
The recommendations are listed in a draft good practice guide jointly issued by the European Medicines Agency and the EU Heads of Medicines Agencies on 27 September. When finalized, the guide will help stakeholders to use the EU metadata catalog of real-world databases, which is due to be released in late 2023.
The guideline has been issued to help deliver a key priority recommendation of the EMA/HMA Big Data Task Force, issued in 2020, on promoting data discoverability through the identification of metadata. (Also see “EU Panel Outlines Practical Way Forward With Big Data” – Pink Sheet, 20 Jan, 2020.)
Metadata are descriptive data that can help characterize other data. In case of a document, for example, metadata may include information on its author, file size, key words, etc. In the case of RWD sources, it may include information on the generation, location and ownership of datasets such as electronic health records and disease registries.
Accessing a “standard and electronic set of complete and accurate metadata information can contribute to identifying the data sources suitable for a specific study, facilitate description of the data sources planned to be used in a study protocol or research proposal, and contribute to assessing the evidentiary value of the results of studies,” the draft guideline explains.
Comments on the draft will be accepted until 16 November.
Metadata List And Catalogs
The draft guide is a central part of several related initiatives being run by the EMA/HMA to help identify metadata for regulatory decision-making. (Also see “EMA Works On Defining Metadata From RWD Sources” – Pink Sheet, 25 Feb, 2021.)
In June this year, the regulators issued a “list of metadata” for describing real-world data sources and studies. The metadata list will feed into two future EU catalogs, namely:
- The catalog of real-world data sources, which is expected to be ready late next year and will cover information on existing real-world databases. This will replace the existing European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) catalog.
- The catalog of studies, which will cover studies performed on the data sources. This will enhance and replace the existing EU electronic register of post-authorization studies (EU PAS Register).
The draft good practice guideline includes recommendations on using the EU metadata catalog of real-world data sources to help identify RWD sources that are suitable for specific research questions and to assess the suitability of data sources proposed to be used in a study protocol or referred to in a study report. It also provides a detailed description of the required metadata elements.
Source: https://pink.pharmaintelligence.informa.com/PS147070/EU-Drafts-Recommendations-On-Identifying-Suitable-RWD-Sources-For-Studies