EMA Launches First RWE Studies Under Big Data Project
Executive Summary
The European Medicines Agency has partnered with eight institutions having access to real-world healthcare data to enable its DARWIN EU project to deliver real-world evidence to the EU medicines regulatory network when needed.
The European Medicines Agency has commissioned the first set of real-world evidence (RWE) studies to be delivered under its ambitious big data project integrating various real-world databases across the EU under a single secure network called the Data Analysis and Real World Interrogation Network (DARWIN EU).
The EMA announced the launch of three RWE studies on 23 November after selecting the first ever “data partners” for DARWIN EU. These partners are public and private institutions with access to real-world healthcare data from sources such as hospitals, primary care, health insurance, biobanks or disease-specific patient registries.
The data available to these partners will be used for studies to generate RWE that will support scientific evaluations and regulatory decision making, the EMA explained.
One of the RWE studies commissioned by the EMA will focus on the epidemiology of rare blood cancers and will aim to produce information on their prevalence in Europe. The second is on the use of the anti-epileptic drug valproate, and the third will look at the use of antibiotics to inform future work on antimicrobial resistance.
More details about these studies will be issued in due course, including the publication of protocols and reports in the EU PAS (post-authorization studies) register. The EMA said the launch of the three studies marked the “start of a rapid ramp-up” in the number of studies that are to be conducted to support regulatory decision making. The aim is that by 2025 DARWIN EU will deliver approximately 150 RWE studies per year. (Also see "RWE Studies To Hit 100+ Per Year In Europe By 2025" - Pink Sheet, 1 Aug, 2022.)
Data Partners
In selecting the first round of data partners for DARWIN EU, the EMA identified eight institutions after consultation with the network’s advisory board. The institutions were selected based on the following criteria:
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Continuous data collection with at least annual data updates.
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A lag time of less than six months in data availability for analysis and capture of health outcomes and medicines prescribing or dispensing.
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Data converted into the Observational Medical Outcomes Partnership (OMOP) common data model, which allows analyses to be performed using the same analytical code.
There are plans to increase the number of data partners gradually, with the target of least 10 new partners being added every year. To this end, the EMA will launch a call for expressions of interest for potential new data partners in 2023.
The agency said it was only looking at data sources that represent different healthcare settings of medicines use (primary, secondary, specialist use) as well as the EU population collectively. “Non-EU data sources can be considered for inclusion if they add value to real-world evidence analyses and enrich the results for decision making on medicines,” it added.