Real-World Data (RWD) are today considered one of the best and most reliable sources of information about the use of drugs, as they are collected during the routine way medicines are prescribed and used in everyday clinical settings. The EMA report on Real-World Data (RWD) is of particular interest to regulators, who look at these data with great attention and scrutiny, as they frequently signal unusual adverse reactions or emerging safety concerns. For this reason, the European Medicines Agency (EMA) has published its second report on the use of Real-World Data (RWD) in scientific studies, fulfilling the Big Data Steering Group’s workplan for monitoring and optimizing medicine use. This report, covering the period from February 2023 to February 2024, highlights the significant progress of DARWIN EU, which officially entered its operational phase during this time. DARWIN EU expanded its data partners from 10 to 20, allowing it to access information from a remarkable 130 million patients spread across 13 European countries. This vast network of real-world data completed or continued 40 studies, which have been instrumental in supporting various decision-makers, including regulators and healthcare professionals, in making more informed decisions regarding medicines. The report also provides a thorough review of previous recommendations, highlights valuable lessons learned throughout the process, and suggests further steps to enhance the collection and utilization of real-world data. Detailed data, including information on the studies and findings, are available in the HMA-EMA RWD Catalogues, which serve as a key resource for those involved in medicines development and regulation. The report demonstrates the growing role of real-world data in advancing regulatory science and improving patient outcomes.1

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References

  1. Real-world evidence | European Medicines Agency (EMA). (2022, October 6). European Medicines Agency (EMA). https://www.ema.europa.eu/en/about-us/how-we-work/big-data/real-world-evidence#use-of-real-world-evidence-68332

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