The European Medicines Agency (EMA) and the European Medicines Regulatory Network established a coordination centre to provide timely and reliable evidence on the use, safety and effectiveness of medicines for human use, including vaccines, from real world healthcare databases across the European Union (EU).

This capability is called the Data Analysis and Real World Interrogation Network (DARWIN EU®).

How does DARWIN EU make health data count?
Cover of the fourth annual report on regulatory-led studies using RWD
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Fourth annual report on regulatory-led studies using RWD published

EMA has published the fourth annual report on regulatory-led studies using RWD. This report outlines the progress in integrating real-world evidence (RWE) into regulatory decision-making, aligned with the European Medicines Regulatory Network (EMRN) strategy to 2028 and in anticipation of the provisions from the new pharmaceutical legislation. It comprises two RWE generation pathways coordinated by the European Medicines Agency (EMA): DARWIN EU®, and studies commissioned via framework contracts.

Highlighted Studies

Visual abstracts for ten key DARWIN EU® studies

CDM Onboarding

CdmOnboarding is an R Package to support the onboarding process of a Data Partner (DP) into the DARWIN EU® Data Network. It extracts statistics from the DP's OMOP CDM instance and produces a Word document. The goal of this onboarding report is to provide insight into the completeness, transparency and quality of the performed Extraction Transform, and Load (ETL) process and the readiness of the data partner to be onboarded in the DARWIN EU®  data network and participate in DARWIN EU® studies.

The onboarding report consists of three sections. The Clinical Data section reports on data table counts, data density, follow-up period length and date ranges. The Vocabulary Mapping section is especially important for data quality, as it shows the concept mapping coverage per domain and the top mapped/unmapped codes. Finally, the Technical Infrastructure section gives insight into the readiness of the DP to execute studies, with overviews of the query timings, installed packages and system information.

CdmOnboarding is run on-site by the DP, and extracts data directly from the OMOP CDM and from pre-calculated tables from Achilles (OHDSI R package for OMOP CDM characterisation). The resulting Word document is required as an annex to the main Onboarding Document, to be delivered upon first onboarding. However, CdmOnboarding is required to be run on every CDM refresh, and results shared with the CC for inspection.

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