DARWIN EU Real-World Evidence Studies Begin

December 2, 2022

The first real-world evidence (RWE) studies have begun in the DARWIN EU initiative of the European Medicines Agency (EMA). The project is a collaboration between the European Commission and the health technology assessment bodies of 27 member countries. Through the project, members hope to support and optimize the use of RWE in regulatory decision-making.

According to Nick Paul Taylor, “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.”

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(Source: RAPS, December 1st, 2022)

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