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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®, 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.

These first four studies start to demonstrate the benefits of DARWIN EU®. 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. The studies were not linked to individual medicines currently under evaluation procedures but selected based on previous procedures and requests for RWE from EMA committees.

Based on this success DARWIN EU® has ambitious plans to onboard ten additional data partners and initiate around 16 studies. By 2025 DARWIN EU® will be fully operational, delivering around 150 RWE studies per year.

Edward Burn Senior Researcher in Epidemiology and Health Economics, and co-lead on DARWIN EU® at NDORMS said: 'I am delighted and extremely proud of the work done by our team. DARWIN EU® is an ambitious multidisciplinary collaboration, and our work has been fundamental to galvanise this initiative.'

DARWIN EU® is a platform to generate real-world evidence (RWE) to support the decision-making of EMA scientific committees and national competent authorities in EU Member States throughout regulatory processes. RWE refers to information derived from analysis of RWD, which is routinely collected data about a patient's health status or delivery of healthcare. RWE complements the evidence generated by randomised controlled clinical trials and contributes to more data-driven regulatory decision making.

Annika Jödicke, Senior Research Associate in Pharmaco-epidemiology at NDORMS added: 'There is a huge need for high-quality studies to support regulatory decision making, and with DARWIN EU we will be able to generate rapid and reliable evidence in the future.'

The EU's vision is that by then the use of RWE will have been enabled and value established across the spectrum of regulatory use cases.