EMA Expands Real-World Data Capacity

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The European Medicines Agency (EMA) announced on March 6, 2024 that the Data Analysis and Real World Interrogation Network, DARWIN EU, has plans to expand capacity for real-world data (RWD) studies in 2024 by adding 10 new data partners. The network currently includes 20 public or private institutions from 13 European countries with access to data from approximately 130 million patients in Europe.

In the two years since the project was started, 14 RWD studies have been completed and 11 are ongoing. Topics of studies include drug utilization, vaccine effectiveness, disease epidemiology, and patient characterization. Recent completed studies include (1):

• A study examined treatment patters in adults and children with systemic lupus erythematosus (SLE). Results were provided to EMA’s Pediatric Committee for the potential use in clinical trials and to see the similarities between adults and children.
• Another study looked at more than 30,000 patients diagnosed with multiple myeloma between 2012 and 2022 in Europe. The study was the first of two pilots to gather data on patient characteristics, treatment patters, and chances of survival for these patients.
• A utilization study was conducted to understand the use pattern of endothelin receptor antagonists and phosphodiesterase-5 inhibitors in pulmonary arterial hypertension.
• An investigation on the annual incidence and prevalence of the use of opioids in seven countries was conducted to determine duration of prescription opioid use, characterization of users, and prescribing and dispensing indications. A study on the use of Take-Home Naloxone to treat opioid overdose was also conducted.
• A cohort study to estimate background rates of serious adverse events and causes of death in severe asthma was conducted.

Study results for these and other studies will be shared with relevant EMA committees and stakeholders. Results will be scaled up with onboarding of data from new partners added in 2024 and 2025. The project aims to conduct 70 RWD studies in 2024 and other 140 studies per year from 2025 onward.

The DARWIN EU project was initiated in 2022 between EMA and the European Medicines Regulatory Network as a coordination center to provide evidence on the use, safety, and effectiveness of medicines in a timely and reliable manner. Data regarding diseases, populations, and performance of medicines are collected from real-world healthcare databases across the European Union. Data obtained by DARWIN EU are converted into a common data model, and the data are kept local and analyzed locally by data partners.

These data are used by EMA and national competent authorities in the EU to make regulatory decisions. DARWIN EU supports EU regulators by establishing a catalogue of observational data sources, by providing validated real-word data, and by carrying out non-interventional studies. The project became fully operational in 2024, which includes involvement from both data partners and regulators as well as the ability to conduct studies and provide answers to EMA scientific committees and national competent authorities. The next goal is for DARWN EU to leverage the data obtained and increase geographical coverage and scope.

The project gathers data from partners in The Netherlands, Belgium, United Kingdom, France, Portugal, Spain, Norway, Finland, Estonia, Denmark, German, Hungary, and Croatia. The initiative projects adding approximately 20 additional partners by the end of 2025. Protocols and results of all DARWIN EU studies are publicly available in the HMA-EMA catalogue of RWD studies.

Reference

1. HMA and EMA. Big Data Steering Group (BDSG): 2023 Report. Jan. 18, 2024.

Source: EMA