MINERVA: Metadata for data discoverability and study replicability in observational studies – quantitative metadata describing the CPRD Aurum data source

Study type
Feasibility Study
Date of Approval
Study reference ID
FS000297
Lay Summary

A catalogue to describe European data sources, for use in medicines regulatory research and surveillance, is being developed. The catalogue will contain descriptions of at least ten data sources, based on expert knowledge. The European Medicines Agency (EMA) intend to use this catalogue to help future researchers identify suitable data sources for studies of the safety and effectiveness of medicines and support these studies with the information described in the catalogue.

For a few data sources, the project aims to collect numerical summaries of data sources, including the number of people included in the database and a summary of the sex and age distributions of the people in the database.

In this study, we aim to provide annual population counts, per sex and age group, from the CPRD Aurum GP database, to the POC catalogue.

Technical Summary

As a part of the EMA-funded project “Metadata for data discoverability and study replicability in observational studies” (EU PAS register number: EUPAS39322), a proof-of-concept (POC) catalogue to describe European data sources, for use in medicines regulatory research and surveillance, is being developed.

We aim to contribute quantitative metadata on CPRD Aurum to the POC catalogue.

Annual population counts (2015-2020), stratified by sex and age group (and age group per sex), will be extracted from the CPRD Aurum denominator table.

Sex will be defined as Male, Female, Other. Age groups will be defined in years as: 0-9, 10-19, 20-29, 30-39, 40-49, 50-59, 60-69, 70-79, 80+.

The resulting counts per year will be uploaded to the EMA POC catalogue.

Health Outcomes to be Measured

None

Collaborators

Romin Pajouheshnia - Chief Investigator - Utrecht University
Romin Pajouheshnia - Corresponding Applicant - Utrecht University
Patrick Souverein - Collaborator - Utrecht University