Two Key Publications from the SIGMA-led MINERVA Project Highlight Metadata Standards for Real-World Data in Europe
2 September 2024
The SIGMA Consortium is excited to announce the publication of the two key articles resulting from the Metadata for Data dIscoverability aNd Study rEplicability in obseRVAtional Studies (MINERVA) project, a project funded by the European Medicines Agency (EMA) which initiated in November 2020 in response to the Heads of Medicines Agencies–European Medicines Agency (HMA–EMA) joint Big Data Task Force recommendation to enable data discoverability through “the identification of metadata” for regulatory decision-making on the choice of data source.
The main article by Pajouheshnia et al, titled "Metadata for Data dIscoverability aNd Study rEplicability in obseRVAtional Studies (MINERVA): Development and Pilot of a Metadata List and Catalogue in Europe” describes the MINERVA project, which was aimed to define a set of metadata to describe real-world data sources and pilot metadata collection in a proof-of-concept catalogue to assist investigators from data source discoverability through study conduct. The article highlights the creation of a list of 442 metadata elements organized within six interconnected domains: institutions, data banks, data sources, studies, networks, and common data models (CDMs). Metadata collection was piloted by 15 data access partners from across Europe, and the catalogue prototype was implemented using the open-source software MOLGENIS.
The companion article by Gini et al, titled "Metadata for Data dIscoverability aNd Study rEplicability in obseRVAtional Studies (MINERVA): Lessons Learnt From the MINERVA Project in Europe," builds on the findings of the main article and focuses on the lessons learnt and recommendations from the project. The article emphasizes the importance of creating a community of FAIR (findable, accessible, interoperable, and reusable) metadata catalogues and highlights the need for persistent identifiers (PIDs) for key objects, mapping metadata lists to a master data model, and establishing global ontologies for metadata. It also discusses the challenges and solutions associated with populating and maintaining metadata catalogues, including the need for a Catalogue Quality Office (CQO) and the importance of version control and robust authentication systems, among other recommendations.
Both articles underscore the significance of metadata in improving the transparency and reproducibility of real-world evidence. The MINERVA metadata list and catalogue prototype were designed to provide a comprehensive standard for the representation of diverse real-world data sources, capturing the knowledge and experience of data experts. This could then be used by investigators throughout the research cycle – to identify suitable data sources for a study, support the design and implementation of the analysis, and help with the interpretation and reporting of findings, by providing insights into the strengths and limitations of a data source.
The MINERVA Consortium worked closely with the EMA Data Analytics and Methods Task Force team to ensure the success of this impactful project. The collaboration was pivotal in laying the foundations for the 2024 launch of the HMA-EMA Catalogues of real-world data sources and studies designed to improve the discoverability and replicability of studies using real-world data, facilitate the discoverability and suitability assessment of data sources to generate real-world evidence for regulatory purposes, improve interoperability between studies and data sources, and improve transparency.
The SIGMA Consortium collaborated closely with the EU PE & PV network on this project. SIGMA Member Organisation RTI Health Solutions serving as the project coordinating center and SIGMA Members Aarhus University, ARS Toscana, BIPS GmbH, Bordeaux PharmacoEpi Platform, FISABIO, IDIAP JGol, Karolinska Institute, PHARMO Institute, UMCU and Utrecht University, among other collaborating institutions, played a crucial role in these achievements. We are proud to have been part of the MINERVA project and look forward to continuing its work in advancing the use of real-world data in medicines development. For more information about the MINERVA project, please visit the MINERVA Study Registration in the HMA-EMA Catalogue of studies or contact us directly.
