The European Medicines Agency (EMA) has begun the first real-world evidence (RWE) studies under its DARWIN EU initiative, kicking off three projects at the start of the “rapid ramp-up” of a program intended to support regulatory decision making.

DARWIN (Data Analysis and Real World Interrogation Network) EU is designed to give EMA, the European Commission and national competent authorities in the 27 member states access to the results of analyses of real-world healthcare databases. EMA named Erasmus University Medical Center Rotterdam as the DARWIN EU coordination center in February.
 
The first three studies will look at the epidemiology of rare blood cancers to understand their prevalence in Europe; the use of the teratogenic epilepsy drug valproate; and the use of antibiotics to inform future work on antimicrobial resistance. EMA will share more details of the studies, including their protocols, in the future.
 
Initially, DARWIN EU will rely on data from eight partners including the Clinical Practice Research Datalink GOLD at Oxford (UK) University and  and Bordeaux University Hospital, France. EMA selected the first batch of data partners according to its prioritization criteria, which favor organizations that have continuous data collection with at least annual data updates and a lag time of less than six months in data availability for analysis.
 
EMA wants to grow the program quickly in the coming years. The agency plans to add at least 10 new data partners every year and aims to scale up the research agenda to deliver around 150 RWE studies a year by 2025. 

Source: Euro Roundup: EMA starts first real-world evidence studies under DARWIN EU | RAPS