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The European Medicines Agency (EMA) initiative DARWIN EU® has completed its first studies and is calling for new data partners

DARWIN EU® success leads to expansion

DARWIN EU®, the Data Analysis and Real-World Interrogation Network, was established a year ago. Following the set-up of the DARWIN EU® Coordination Centre in February 2022, the first ten data partners were onboarded and NDORMS joined to contribute data and the analysis of drug and vaccine safety.

The network initiated its first four studies using real-world data (RWD) from across Europe to better understand diseases, populations and the uses and effects of medicines.

  • DARWIN EU®'s first 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 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 study aimed 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 review.
  • The fourth study is on severe asthma and its final results are expected in spring 2023. The study will inform the safety assessment of all products authorised or under development for the treatment of severe asthma in adolescents and adults.

Read the full story on the Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences website.