Study identification

EU PAS number

EUPAS39322

Study ID

49345

Official title and acronym

Strengthening Use of Real-World Data in Medicines Development: Metadata for Data Discoverability and Study Replicability (MINERVA)

DARWIN EU® study

No

Study countries

Austria
Belgium
Czechia
Denmark
Estonia
France
Germany
Italy
Netherlands
Slovenia
Spain
Sweden
Switzerland
United Kingdom

Study description

Identification of appropriate data sources is becoming an increasing need for regulatory decision making. Metadata are descriptive data that characterise other data to create a clearer understanding of their meaning and achieve greater reliability and quality of information. Access to a standard and electronic set of complete and accurate metadata information can contribute to identifying the datasources that are most suitable for a specific study, describe the datasources planned to be used in a study protocol or research proposal, and contribute to assessing the evidentiary value of the results of a multidatabase observational study submitted in a study report or publication. The objective of this study is to define and collect a set of metadata for a selected number of real-world (RW) datasources. The study consists in the preparatory step for the development and population of a publicly available catalogue of sources of RW data characterised with a common set of metadata. The catalogue will serve as a proof of concept for a metadata inventory with searchability, dynamic dashboards, visualisation capabilities, and integration of different levels of access (public vs. confidential information). Specific objectives of this study are:
1. Define a list of criteria to identify relevant RW datasources from which the datasources to be included in this study will be selected.
2. Identify a list of a minimum of 10 datasources for this study.
3.Define a set of metadata that should be collected from RW datasources.
4.Conduct an in-depth stakeholders’ consultation on the metadata identified.
5.Define a process to collect the set of metadata for the datasources in the study.
6.Collect the defined set of metadata for datasources in the study.
7.Develop a tool enabling access to the metadata collected.
8.Draft a good practice guide with the description of the metadata defined and recommendations on its use for the purpose of identifying RW datasources for specific studies.

Study status

Finalised
Research institutions and networks

Institutions

RTI Health Solutions (RTI-HS)
France
Spain
Sweden
United Kingdom
United Kingdom (Northern Ireland)
United States
First published:
13/03/2025
Institution Not-for-profit ENCePP partner
University of Tartu
Estonia
First published:
01/02/2024
Institution Educational Institution
University Medical Center Groningen (The Netherlands), The Spanish Working Group on Chron’s Disease and Ulcerative Colitis (GETECCU) (Spain), University of Ljubljana Faculty of Pharmacy (Slovenia), Institute of Genomics (Estonia)

Networks

The SIGMA Consortium (SIGMA)
Denmark
European Union
France
Germany
Italy
Netherlands
Norway
Spain
Sweden
United Kingdom
First published:
16/12/2024
Network
ENCePP partner

Contact details

Susana Perez-Gutthann 0000-0001-5798-3691

Primary lead investigator
ORCID number:
0000-0001-5798-3691

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
EMA
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

Not applicable