SIDIAP is participating in European Medicines Agency’s DARWIN EU network

The IDIAPJGol’s database, which includes information on Primary Care records from Catalonia, was selected to be part of the new DARWIN EU® network dedicated to support regulatory decision-making throughout the lifecycle of medicinal products

The European Medicines Agency (EMA) launched, in 2022, the Data Analysis and Real-World Interrogation Network (DARWIN EU®) with the aim to provide real world evidence to facilitate regulatory decision-making, support scientific evaluations and contribute to developing and authorizing safe and effective use of medicines in Europe.

In the first year of the network, EMA has selected 10 Data partners from different European countries to be part of DARWIN EU®. One of them is SIDIAP, the database of the Jordi Gol Primary Care Research Institute (IDIAPJGol) which includes information from Primary Care electronic health records from Catalonia. The SIDIAP contains longitudinal pseudo-anonymised information from more than 7 million people and it’s already transformed to an international common data model, called OMOP. This database has previously been used to generate scientific evidence in several 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 of 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:

• DARWIN EU®’s first disease epidemiology studyinvestigated the prevalence of rare blood cancers in five European countries.
• The second studyfocused on the use of medicines containing valproate and alternative therapies among girls and women between 12 and 55 years of age, in light of the potential of these types of medicines to cause harm to unborn babies.
• The third studyaimed to characterise prescription patterns for 141 antibiotics from the Watch list of the WHO AWaRe classification. The results will serve as additional evidence in the monitoring of antibiotic use as part of the work on antimicrobial resistance and help to guide product information and guideline
• The fourth studyis on severe asthma and its final results are expected in summer 2023. This study will inform on the safety assessment of all products authorised or under development for the treatment of severe asthma in adolescents and adults.

The first four studies start to demonstrate the benefits of the DARWIN EU® network. The use of a common data model, standardised analytics and agile processes allow faster performance of studies, increased capacity, and lower costs. The design and conduct of these first studies have also supported the establishment of analytical pipelines and 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, lead of the Real World Epidemiology research group at IDIAPJGol. "This is the fruit of many years of work from the SIDIAP team to provide high-quality data for research purposes, as well as the work from our team to map the SIDIAP database to the OMOP common data model. DARWIN EU® will revolutionize 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."