EMA reports uptick in RWD studies, growth in DARWIN network

The European Medicines Agency (EMA) reported that between February 2024 and February 2025, 59 studies utilizing real-world evidence (RWE) were conducted using its various evidence generation pathways.

This represents a 47.5% increase compared to the previous year. The report also noted that the Data Analysis and Real-World Interrogation Network (DARWIN) became the primary pathway for generating evidence, experiencing a threefold increase in competing studies.

The report represents the third annual analysis of regulators' use of real-world data (RWD) and coincides with the launch of DARWIN and the European Medicines Regulatory Network (EMRN) in 2022. (RELATED: EMA, HMA outline evolution of DARWIN EU real-world database, Regulatory Focus 2 August 2022)

EMA stated that, due to the efforts made over the past four years to promote its use, RWE is now accepted and “its value continues to be established across the full range of regulatory use cases.”

The report addresses RWE generated for the EMRN and other stakeholders, the value of RWE, methodological RWE advice, and progress made since the last report.

Out of 59 studies, EMA reported that 33 have been completed, while 26 are still ongoing. Among the completed studies, 25 were carried out within the DARWIN EU initiative, marking a nearly three-fold increase from the previous reporting period, which only had nine studies. The remaining studies were either commissioned to external partners or conducted internally.

The report indicates that during this period, the capacity of DARWIN EU was expanded, becoming the primary pathway for evidence generation in EMA-led studies, with nearly three times as many completed studies compared to the previous reporting period.

The DARWIN network grew in 2024 to include 30 data partners across 16 countries, covering approximately 180 million patients and offering more opportunities.

During the reporting period, 107 research topics were investigated for feasibility across 14 therapeutic areas. The most frequently studied area was anti-infectives, which accounted for 22 research topics. Following that were antineoplastic and immunomodulating agents, with 19 research topics, and treatments for the nervous system, which included 17 research topics.

Most of the research focused on drug utilization (42%), safety (24%), and disease epidemiology (24%).

These research topics were requested by regulatory and public health officials, including EMA scientific committees and working groups, the European Centre for Disease Prevention and Control (ECDC), health technology assessment bodies/payers, and the European Commission (EC).

EMA's Pharmacovigilance Risk Assessment Committee and its Pediatric Committee (PDCO) requested most of the new research topics during the reporting period. PDCO also had the highest percentage of unfeasible requests. EMA attributed the denials due to the rarity of these diseases in children, the small population size, and limited sources which specialized in pediatrics.

Completed studies assessed the potential link between doxycycline use and suicide risk. Another assessed the safety and effectiveness of MVA-BN vaccination used to prevent smallpox and monkeypox for at-risk individuals in Germany. Other studies looked at anti-migraine medicines to assess safety signals on insomnia, erectile dysfunction and high blood pressure, and a respiratory syncytial virus (RSV) and its impact on vulnerable populations such as infants and older adults.

The EMA also reported that “significant improvements” have been made over the past year in how the agency assesses the quality of data and utilizes this information to address various questions. These advancements are attributed to more consistent definitions of health and drug conditions.

EMA said that future plans in the RWD space include concentrating more on specific clinical areas, including oncology, metabolic, and cardiovascular specialties, and targeted populations like pediatrics. Additionally, there are plans to examine large data sources in countries beyond the EU.

Report

EMA reports uptick in RWD studies, growth in DARWIN network

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