The European Medicines Agency published a report last week discussing the use of real-world evidence (RWE) in clinical trials and regulatory decisionmaking, the benefits it can provide, and the challenges in doing so. RWE, according to the report, is widely used in pharmacovigilance studies, but its use in early drug development still faces uncertainties.
According to the EMA, “The report covers the period from September 2021 until the first anniversary of the Data Analysis and Real-World Interrogation Network DARWIN EU® on 7 February 2023. During this period, 61 RWD research opportunities were identified, 30 studies initiated and 27 completed.”
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(Source: European Medicines Agency, June 26th, 2023)