The European Medicines Agency (EMA) launches the Data Analysis and Real-World Interrogation Network (DARWIN EU®), a network of databases designed to conduct studies using “real-world data”, information routinely collected on an individual’s health status or the provision of healthcare services, from a variety of sources that differ from traditional clinical trials. The aim of the network is to facilitate regulatory decision-making, support scientific assessments, and contribute to the development, authorization, and safe and effective use of medicines at the European level.

In the first year of the network, the EMA selected 10 data partners from different European countries to be part of DARWIN EU®. One of them is SIDIAP, the database of the Primary Care Research Institute Jordi Gol (IDIAPJGol), which includes information from the electronic medical records of Primary Care in Catalonia. SIDIAP contains pseudonymised longitudinal information from more than 7 million people and has already been transformed into an international common data model called OMOP. This database has previously been used to generate scientific evidence on various topics, including the use, safety, and effectiveness of medicines and vaccines.

The first four studies

SIDIAP’s participation in the DARWIN EU® network has been led by the Real World Epidemiology research group at IDIAPJGol. This group has also led the mapping of the SIDIAP database to the OMOP common data model and the participation in the first four studies of the DARWIN EU® network, which are:

• The first DARWIN EU® disease epidemiology study investigated the prevalence of rare blood cancers in five European countries.
• The second study focused on the use of medicines containing valproate and alternative therapies among girls and women aged 12 to 55, in light of the potential of this type of medicine to cause harm to unborn babies.
• The third study aimed to characterise the prescription patterns of 141 antibiotics from the WHO AWaRe classification watchlist. The results will serve as additional evidence in monitoring antibiotic use as part of work on antimicrobial resistance and will help guide product information and guideline review.
• The fourth study is on severe asthma and its final results are expected at the end of summer 2023. This study will inform the safety assessment of all authorised or in-development products for the treatment of severe asthma in adolescents and adults.

These first four studies are beginning to demonstrate the benefits of the DARWIN EU® network. The use of a common data model, standardised analysis, and agile processes allows for faster study performance, increased capacity, and reduced costs. The design and execution of these first studies have also contributed to establishing standard analytical processes.

“It is an honour to have been selected as one of the first data partners to be part of DARWIN EU®,” says Talita Duarte-Salles, principal investigator of the Real World Epidemiology research group at IDIAPJGol. “This is the result of many years of work by the SIDIAP team to provide high-quality data for research purposes, as well as the work of our team to map the database to the OMOP common data model. DARWIN EU® will revolutionise the way we use real-world data for regulatory purposes in Europe, providing the tools needed to generate fast and reliable evidence. It is very exciting to be part of this network.”

IDIAPJGol, research that touches you closely

The Jordi Gol i Gurina Primary Healthcare University Research Institute Foundation (IDIAPJGol) is a reference centre for research and health promotion in primary care. Its objective is to promote and develop innovation, as well as clinical, epidemiological, and healthcare services research in the field of primary care, and to provide training with the aim of generating knowledge, disseminating results, and transferring them into clinical practice to improve the efficiency of the healthcare system and promote and improve people’s health.