(166) MINERVA: Metadata for Data Discoverability and Study Replicability in Observational Studies

Sunday, August 28, 2022

8:00 AM – 1:45 PM CEST

Location: Hall C

Publication Number: 1211

Presenting Author(s)

Lia Gutierrez, MPH, BScN
– Senior Epidemiology Director , RTI Health Solutions, University of Texas School of Public Health, Houston, BARCELONA, Barcelona, Spain

Co-Author(s)

Rosa Gini, PhD
– Agenzia Reg Della Sanit, Firenze, Firenze, Italy
Romin Pajouheshnia, PhD
– Assistant Professor (formerly), University of Utrecht, The Hague, Zuid-Holland, Netherlands
Eleanor Hyde
– University Medical Center Groningen, Netherlands
Morris A. Swertz
– University Medical Center Groningen, Netherlands
Miriam C. Sturkenboom, PharmD, PhD, FISPE
– prof. dr., University Medical Center Utrecht, Utrecht, Utrecht, Netherlands
Andrea V. Margulis, FISPE
– RTI Health Solutions, BARCELONA, Barcelona, Spain
Carla Franzoni
– RTI Health Solutions, Spain
Alejandro Arana
– RTI Health Solutions, Spain
Vera Ehrenstein, MPH, DSc
– Aarhus University, Aarhus, Denmark
Karin Gembert
– Centre for Pharmacoepidemiology, Karolinska Institutet, Stockholm, Sweden, Sweden
Ella Jansen
– PHARMO Institute for Drug Outcomes Research, Utrecht, Netherlands, Utrecht, Utrecht, Netherlands
Ron Herings, PharmD, PhD, FISPE
– Director, PHARMO Institute for Drug Outcomes Research, Utrecht, Netherlands, Utrecht, Utrecht, Netherlands
Nicolas H. Thurin, PharmD, PhD
– Scientific Officer, Bordeaux PharmacoEpi, Université de bordeaux, Bordeaux, France
Igor Locatelli
– University of Ljubljana, Faculty of Pharmacy, Slovenia
Janja Jazbar
– University of Ljubljana, Faculty of Pharmacy, Slovenia
Špela Žerovnik
– University of Ljubljana, Faculty of Pharmacy, Ljubljana, Slovenia
Mitja Kos
– University of Ljubljana, Faculty of Pharmacy, Slovenia
Steven Smit, MSc
– Head of the Biobank Lab, Estonian Genome Center, Institute of Genomics, University of Tartu, Tartu, Tartumaa, Estonia
Sirje Lind
– Estonian Genome Center, Institute of Genomics, University of Tartu, Tartu, Tartumaa, Estonia
Andres Metspalu
– Estonian Genome Center, Institute of Genomics, University of Tartu, Estonia
Silvia Zaccagnino
– European Society for Blood & Marrow Transplantation, Spain
Maria Paula Busto
– European Society for Blood & Marrow Transplantation, Netherlands
Bas Middelkoop
– European Society for Blood & Marrow Transplantation, Netherlands
Manuel Barreiro-De Acosta
– Spanish Working Group on Crohn’s Disease and Ulcerative Colitis- GETECCU, Spain
Francisco Sanchez-Saez, PhD
– Foundation for the Promotion of Health and Biomedical Research of Valencia Region, Valencia, Valencia, Spain
Clara Rodriguez-Bernal
– Foundation for the Promotion of Health and Biomedical Research of the Valencia Region, Spain, Valencia, Comunidad Valenciana, Spain
Gabriel Sanfelix-Gimeno
– Foundation for the Promotion of Health and Biomedical Research of Valencia Region, Valencia, Valencia, Spain
Beatriz Poblador-Plou
– Instituto Aragonés de Ciencias de la Salud,IIS Aragon, Spain, Aragon, Spain
Jonás Carmona-Pírez
– Instituto Aragonés de Ciencias de la Salud, Spain, Aragon, Spain
Antonio Gimeno-Miguel
– Researcher, Instituto Aragonés de Ciencias de la Salud, Spain, Zaragoza, Aragon, Spain
Miguel Gil, MD, MPH, phD
– Senior Epidemiologist, Agencia Española de Medicamentos y Productos Sanitarios, Spain, Madrid, Madrid, Spain
Wiebke Schaefer, MSc
– Leibniz Institute for Prevention Research and Epidemiology - BIPS, Bremen, Germany
Ulrike Haug
– Prof. Dr. sc. hum., Leibniz Institute for Prevention Research and Epidemiology - BIPS, Bremen, Germany
Stefania Simou
– European Medicines Agency, Netherlands
Chantal Quinten, PhD
– Scientific Administrator, European Medicines Agency, Amsterdam, Noord-Holland, Netherlands
Ana Cochino
– European Medicines Agency, Netherlands
Paolo Alcini
– European Medicines Agency, Netherlands
Xavier Kurz, MD
– Head of Data Analytics, European Medicines Agency, Amsterdam, Noord-Holland, Netherlands
Susana Perez-Gutthann, MD, PhD, MPH, FISPE, FRCP
– VP Epidemiology, RTI Health Solutions, BARCELONA, Barcelona, Spain

Background: Identification of real-world data sources (RWDS) for valid and relevant pharmacoepidemiologic research requires comprehensive assessment of their characteristics and contents. This European Medicines Agency (EMA)–commissioned project (EUPAS39322) stemmed from the joint Heads of Medicines Agencies–EMA Big Data Task Force recommendations.

Objectives: - Define a set of metadata and pilot metadata collection in a proof-of-concept catalogue
- Provide recommendations on a sustainable metadata collection process and use for identifying RWDS for specific regulatory use cases.

Methods: MINERVA, a partnership of 18 research centers in 12 European countries, worked with 15 RWDS. A list of candidate metadata was derived from public resources and structured interviews with external experts. The list of metadata was finalised after feedback from the EMA and from a variety of stakeholders during a technical workshop in which the preliminary metadata list and a proposed process for collecting and maintaining metadata in a catalogue were reviewed. A proof-of-concept catalogue was built based on the FAIR principles using the open-source software MOLGENIS. The catalogue population was piloted following two processes: i) import of metadata from a preexisting catalogue and ii) collection using an interview tool. Collection of quantitative data was piloted in four data sources and a script. Quality checks were performed by an investigator to review the population of the metadata. Results of the pilot informed a set of recommendations.

Results: The metadata list included 436 variables; 241 labelled as priority for regulatory purposes were collected in the pilot. The proof-of-concept catalogue was divided into the following domains: Institutions, Data Sources, Data Banks, Common Data Models, Networks, and Studies. Considerable resources were required for entry and review of qualitative metadata to ensure metadata concepts and terminology were interpreted consistently across contributors to the catalogue entries. Quantitative metadata (age and gender distribution) were retrieved from four data sources by a script supporting four common data models. The 15 data sources included a variable number of data banks ranging from 1 to 16. Completeness of qualitative metadata varied across data sources. Recommendations were compiled in a guidance document available in the EU PAS register.

Conclusions: The MINERVA pilot showed the value of piloting major catalogue processes and a need for data curation. The challenges and limitations encountered should be taken into account in future metadata catalogues.