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Home » EMA Touts its New Real-World Evidence Capabilities to Researchers
EMA Touts its New Real-World Evidence Capabilities to Researchers
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April 29, 2024
The European Medicines Agency (EMA) has released a document detailing how the agency’s real-world evidence (RWE) office can help with clinical trials.
The document, which explains how to ask EMA to run research-related questions through its RWE sources, describes how RWE can be useful in the context of regulatory decision-making, the types of studies that can be performed and how EMA can help identify the best resources to address a research question. The process for requesting real-world data (RWD) studies is also explained. It comes two months after the EMA and the Heads of Medicines Agencies (HMA) launched two public electronic catalogues, one for RWD sources and one for RWD studies.
The EMA — which is in a phase of scaling up its capacity to generate RWE using electronic health records through the Real-World Evidence Team (TDA-RWE) of its Data Analytics and Methods Task Force — said the publication of the RWD catalogues brings the European medicines regulatory network closer to more data-driven regulation.
Improving discoverability of data is one of the priorities set in the HMA-EMA joint Big Data Task Force final report, reflected in the agencies’ network strategy for 2025 and implemented through the joint HMA-EMA Big Data Steering Group workplan.
“Ultimately, these developments will help European patients receive better medicines faster and promote safe and effective use of the medicines on the market,” said the EMA in a statement.
The agency said a feasibility assessment on whether a specific research question can be best answered using RWE can be produced within a few days or weeks, while simple studies can be carried out within six to eight weeks and more complex studies can take up to several months.
In the document, the agency said it will maintain standards of its RWD by continually reviewing processes and testing methodologies to ensure it can consistently deliver high-quality results, and then subsequently valid and reliable evidence, within the required timelines.
“The landscape is ever changing with new data sources and new options for analyses becoming ever more available,” wrote the EMA.
As it does more with RWE, the EMA will share its new experiences in regular public reports.
Read the EMA’s document on RWE here.
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