DARWIN EU, acronym for Data Analysis and Real World Interrogation Network, is the new long-term project of EMA, the European Medicines Agency. The objective is to allow all competent national authorities and European scientific committees to find health data at any time throughout the life of a medicinal product.
The program was officially born in February 2022, when EMA chose the Erasmus university medical center in Rotterdam as its service provider. Together they developed the foundations of the project, from the perspective of government structures, contract models and processes.
The activities of the coordination center
Among its many functions, the coordination center (CC) that has been established must provide timely and reliable evidence on the use, safety and effectiveness of medicines for human use, including vaccines, from real-world health databases of the entire European Union.
Regulatory decision making involves creating and expanding a catalog of observational data sources for use in drug regulation to provide a source of high-quality, validated data on drug uses, safety, and effectiveness.
The aim is to address specific problems through the implementation of high-quality, non-interventional studies, including the development of scientific protocols, the interrogation of relevant data sources, and the interpretation and communication of study results.
The CC must also provide a structure to develop and manage the network of partners, including their training on study processes and methods. Currently the studies are preliminary and can only be commissioned by EMA to test Darwin EU, although it is already possible to express interest in becoming a data partner through a form. Only when the network is wider will EMA be able to commission studies for third parties.
Another function of the coordination center is to evaluate the admissibility of the studies and follow them until the last day, when the results will be integrated into the decision-making processes of European regulations.
To implement all the services necessary to generate reliable real-world evidence, several categories of studies have been established:
- off-the-shelf, mainly deal with common questions that can be solved with a generic protocol
- complex, require the development or customization of specific study designs, protocols, assays and phenotypes
- routine repeated analysis, the studies are repeated, based on the techniques just described, with a specific frequency, for example annually
- very complex, cannot rely only on electronic healthcare databases or require complex and/or new methodological work
Each of these categories must follow a well-defined development process, based on exploration, initiation, implementation, execution and dissemination. To make results usable, analytical processes need to be standardized and automated.
Observational Medical Outcomes Partnership Common Data Model
In particular, to guarantee complete data interoperability, the Observational Medical Outcomes Partnership Common Data Model (OMOP CDM) is used, a standardized model for storing real-world data and developed to facilitate the generation of scientific evidence through observational studies on large scale.
Thanks to this model, it is possible to apply the tools and methods even on different databases. In fact, DARWIN EU is aimed at guaranteeing easy and secure access to health data, regardless of where they are saved.
In the near future, the project will connect the European Medicines Regulatory Network to the European Commission’s European Health Data Area (EHDS), which will enable the exchange of health data to be used for healthcare delivery, policy making and research across Europe, in full compliance with data protection requirements.
The publication of data
Before being disseminated, the evidence is summarized in reports and tables and then examined in the context of prior knowledge. The publication of data occurs in an aggregate and non-patient-specific manner, so that privacy is maintained.
As regards the dissemination phase, the results of the studies are uploaded to the EU PAS register, the European Union’s electronic register of post-authorisation studies. This platform ensures compliance with the legal requirements established by the European Union legislation on pharmacovigilance, increases transparency and reduces publication bias.
The project is still to be completed, but the goal by the end of 2023 is to provide a first catalog of real-world data sources on a website that is available to the public, and then
