Metadata for Data dIscoverability aNd Study rEplicability in obseRVAtional Studies (MINERVA): Development and Pilot of a Metadata List and Catalogue in Europe.
FAIR
catalogue
metadata
observational studies
real‐world data sources
reproducibility
Journal
Pharmacoepidemiology and drug safety
ISSN: 1099-1557
Titre abrégé: Pharmacoepidemiol Drug Saf
Pays: England
ID NLM: 9208369
Informations de publication
Date de publication:
Aug 2024
Aug 2024
Historique:
revised:
30
05
2024
received:
16
06
2023
accepted:
24
06
2024
medline:
15
8
2024
pubmed:
15
8
2024
entrez:
15
8
2024
Statut:
ppublish
Résumé
Metadata for data dIscoverability aNd study rEplicability in obseRVAtional studies (MINERVA), a European Medicines Agency-funded project (EUPAS39322), defined a set of metadata to describe real-world data sources (RWDSs) and piloted metadata collection in a prototype catalogue to assist investigators from data source discoverability through study conduct. A list of metadata was created from a review of existing metadata catalogues and recommendations, structured interviews, a stakeholder survey, and a technical workshop. The prototype was designed to comply with the FAIR principles (findable, accessible, interoperable, reusable), using MOLGENIS software. Metadata collection was piloted by 15 data access partners (DAPs) from across Europe. A total of 442 metadata variables were defined in six domains: institutions (organizations connected to a data source); data banks (data collections sustained by an organization); data sources (collections of linkable data banks covering a common underlying population); studies; networks (of institutions); and common data models (CDMs). A total of 26 institutions were recorded in the prototype. Each DAP populated the metadata of one data source and its selected data banks. The number of data banks varied by data source; the most common data banks were hospital administrative records and pharmacy dispensation records (10 data sources each). Quantitative metadata were successfully extracted from three data sources conforming to different CDMs and entered into the prototype. A metadata list was finalized, a prototype was successfully populated, and a good practice guide was developed. Setting up and maintaining a metadata catalogue on RWDSs will require substantial effort to support discoverability of data sources and reproducibility of studies in Europe.
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
e5871Subventions
Organisme : European Medicines Agency (EMA)
ID : EMA/2017/09/PE/16
Informations de copyright
© 2024 The Author(s). Pharmacoepidemiology and Drug Safety published by John Wiley & Sons Ltd.
Références
X. Kurz, “Darwin EU—First Experience and Regulatory Use Cases,” Data Analytics and Methods Taskforce, European Medicines Agency. EMA/HMA Big Data Stakeholder Forum 2022, accessed December 15, 2022, https://www.ema.europa.eu/en/documents/presentation/session‐2‐1‐darwin‐eu‐r‐first‐experiences‐regulatory‐use‐case‐xavier‐kurz_en.pdf.
M. Wilkinson, M. Dumontier, I. Aalbersberg, et al., “The FAIR Guiding Principles for Scientific Data Management and Stewardship,” Scientific Data 15, no. 3 (2016): 160018, https://doi.org/10.1038/sdata.2016.18.
Heads of Medicines Agencies, European Medicines Agency, “HMA–EMA Joint Big Data Taskforce Phase II Report: Evolving Data‐Driven Regulation,” accessed October 11, 2022, https://www.ema.europa.eu/en/documents/other/hma‐ema‐joint‐big‐data‐taskforce‐phase‐ii‐report‐evolving‐data‐driven‐regulation_en.pdf.
Heads of Medicines Agencies, European Medicines Agency, “Priority Recommendations of the HMA–EMA Joint Big Data Task Force,” HMA–EMA Big Data Steering Committee Group, accessed January 9, 2023, https://www.ema.europa.eu/en/documents/other/priority‐recommendations‐hma‐ema‐joint‐big‐data‐task‐force_en.pdf.
Heads of Medicines Agencies, European Medicines Agency, “Big Data Steering Group,” accessed January 9, 2023, https://www.ema.europa.eu/system/files/documents/work‐programme/workplan‐2023‐2025‐hmaema‐joint‐big‐data‐steering‐group_en.pdf.
A. Pacurariu, K. Plueschke, P. McGettigan, et al., “Electronic Healthcare Databases in Europe: Descriptive Analysis of Characteristics and Potential for use in Medicines Regulation,” BMJ Open 8, no. 9 (2018): e023090.
N. H. Thurin, R. Pajouheshnia, G. Roberto, et al., “From Inception to ConcePTION: Genesis of a Network to Support Better Monitoring and Communication of Medication Safety During Pregnancy and Breastfeeding,” Clinical Pharmacology and Therapeutics 111, no. 1 (2022): 321–331, https://doi.org/10.1002/cpt.2476.
R. Gini, M. C. J. Sturkenboom, J. Sultana, et al., “Different Strategies to Execute Multi‐Database Studies for Medicines Surveillance in Real‐World Setting: A Reflection on the European Model,” Clinical Pharmacology and Therapeutics 108, no. 2 (2020): 228–235.
European Medicines Agency, “Catalogue of RWD Studies,” MINERVA, Final Set of Metadata and Definitions, Process, and Catalogue Tool, accessed May 2, 2024, https://catalogues.ema.europa.eu/sites/default/files/document_files/MINERVA_D5_Report_v1.1_28June2021.pdf.
US Food and Drug Administration, “FDA's Sentinel Initiative,” accessed October 11, 2022, https://www.fda.gov/safety/fdas‐sentinel‐initiative.
Cnodes.ca, “CNODES | Canadian Network for Observational Drug Effects Studies,” accessed October 11, 2022, https://www.cnodes.ca.
Ehden.eu, “European Health Data Evidence Network – ehden.eu,” accessed October 11, 2022, https://www.ehden.eu/.
Imi‐conception.eu, “ConcePTION,” accessed October 11, 2022, https://www.imi‐conception.eu/.
Aspennet.asia, “Asian Pharmacoepidemiology Network 2021,” accessed October 11, 2022, https://aspennet.asia/.
Fairplus‐project.eu, “FAIRplus | Home Page,” accessed October 11, 2022, https://fairplus‐project.eu.
Maelstrom‐research.org, “Home Page | Maelstrom Research,” accessed 11 October 2022, https://www.maelstrom‐research.org.
Aetion, “Real‐World Evidence Solution | RWE Analytics | Aetion,” accessed October 11, 2022, https://aetion.com.
European Medicines Agency, “Technical Workshop on Real‐World Metadata for Regulatory Purposes,” Virtual Meeting, European Medicines Agency, accessed January 16, 2023, https://www.ema.europa.eu/en/documents/other/summary‐report‐technical‐workshop‐real‐world‐metadata‐regulatory‐purposes_en.pdf.
G. C. Hall, B. Sauer, A. Bourke, J. S. Brown, M. W. Reynolds, and R. LoCasale, “Guidelines for Good Database Selection and Use in Pharmacoepidemiology Research,” Pharmacoepidemiology and Drug Safety 21, no. 1 (2012): 1–10.
European Medicines Agency, “Catalogue of RWD Studies. MINERVA Deliverable 2, Selection of Data Sources and Justification: Final,” accessed May 2, 2024, https://catalogues.ema.europa.eu/system/files/2024‐02/MINERVA_DataSourceSelection_Final_26March2021.pdf.
K. J. van der Velde, F. Imhann, B. Charbon, et al., “MOLGENIS Research: Advanced Bioinformatics Data Software for Non‐Bioinformaticians,” Bioinformatics 35, no. 6 (2019): 1076–1078.
EUCAN‐connect, “Catalogue,” accessed April 24, 2023, https://catalogue.eucanconnect.eu/#/.
LifeCycle, “Project Summary,” accessed April 24, 2023, https://lifecycle‐project.eu/about‐lifecycle/project‐summary/.
J. Ronkainen, R. Nedelec, A. Atehortua, et al., “LongITools: Dynamic Longitudinal Exposome Trajectories in Cardiovascular and Metabolic Noncommunicable Diseases,” Environmental Epidemiology 6, no. 1 (2021): e184.
M. Vrijheid, X. Basagaña, J. R. Gonzalez, et al., “Advancing Tools for Human Early Lifecourse Exposome Research and Translation (ATHLETE): Project Overview,” Environmental Epidemiology 5, no. 5 (2021): e166.
The European Human Exposome Network, “Human Exposome,” accessed April 24, 2023, www.humanexposome.eu.
Data Catalogue Vocabulary (DCAT), “Data Catalogue Vocabulary – Version 2,” accessed April 24, 2023, https://www.w3.org/TR/vocab‐dcat‐2/.
GitHub, “Observational Medical Outcomes Partnership Common Data Model,” accessed January 26, 2023, https://ohdsi.github.io/CommonDataModel/.
A. But, M. L. De Bruin, M. T. Bazelier, et al., “Cancer Risk Among Insulin Users: Comparing Analogues With Human Insudalin in the CARING Five‐Country Cohort Study,” Diabetologia 60, no. 9 (2017): 1691–1703.
G. Trifirò, V. Isgrò, Y. Ingrasciotta, et al., “Large‐Scale Postmarketing Surveillance of Biological Drugs for Immune‐Mediated Inflammatory Diseases Through an Italian Distributed Multi‐Database Healthcare Network: The VALORE Project,” BioDrugs 35, no. 6 (2021): 749–764.
European Medicines Agency, “Catalogue of RWD Studies,” MINERVA Deliverable 9, Final Good Practice Guide for Metadata Collection for Real‐World Data Sources, accessed May 2, 2024, https://catalogues.ema.europa.eu/sites/default/files/document_files/MINERVA_GoodPracticeGuide_10Jan2022.pdf.
European Commission, “European Health Data Space,” accessed December 5, 2023, https://health.ec.europa.eu/ehealth‐digital‐health‐and‐care/european‐health‐data‐space_en.
R. Gini, R. Pajouheshnia, L. Gutierrez, et al., “Metadata for Data dIscoverability aNd Study rEplicability in obseRVAtional Studies: Lessons Learnt From the MINERVA Project in Europe: Lessons Learnt on Metadata Catalogues,” Pharmacoepidemiology and Drug Safety (2024), https://doi.org/10.1002/pds.5884.
European Medicines Agency, “List of Metadata for Real World Data Catalogues,” accessed November 23, 2023, https://www.ema.europa.eu/en/documents/other/list‐metadata‐real‐world‐data‐catalogues_en.pdf.
VAC4EU, “Toolbox Catalogue,” accessed December 19, 2023, https://vac4eu.org/catalogue/.
M. A. Swertz, M. Dijkstra, T. Adamusiak, et al., “The MOLGENIS Toolkit: Rapid Prototyping of Biosoftware at the Push of a Button,” BMC Bioinformatics 11, no. 12 (2010): S12, https://doi.org/10.1186/1471‐2105‐11‐S12‐S12.
M. Swertz, E. van Enckevort, J. L. Oliveira, et al., “Towards an Interoperable Ecosystem of Research Cohort and Real‐World Data Catalogues Enabling Multi‐Center Studies,” Yearbook of Medical Informatics 31, no. 1 (2022): 262–272.
R. Gini, R. Pajouheshnia, H. Gardarsdottir, et al., “Describing Diversity of Real World Data Sources in Pharmacoepidemiologic Studies: The DIVERSE Scoping Review,” Pharmacoepidemiology and Drug Safety 33, no. 5 (2024): e5787, https://doi.org/10.1002/pds.5787.
European Medicines Agency, “Catalogue of RWD Studies | HMA–EMA Catalogues of Real‐World Data Sources and Studies (europa.eu),” accessed May 2, 2024, https://catalogues.ema.europa.eu/catalogue‐rwd‐studies.
European Medicines Agency, “Catalogue of RWD Sources | HMA–EMA Catalogues of Real‐World Data Sources and Studies (europa.eu),” accessed May 2, 2024, https://catalogues.ema.europa.eu/catalogue‐rwd‐sources.
European Medicines Agency, “Good Practice Guide for the use of the Metadata Catalogue of Real‐World Data Sources,” V 1.0, accessed November 23, 2023, https://www.ema.europa.eu/en/documents/regulatory‐procedural‐guideline/good‐practice‐guide‐use‐metadata‐catalogue‐real‐world‐data‐sources_en.pdf.