{"id":16718,"date":"2023-07-18T14:18:30","date_gmt":"2023-07-18T14:18:30","guid":{"rendered":"https:\/\/makingpharmaindustry.it\/non-categorizzato\/darwin-eu-towards-easy-and-secure-access-to-health-data\/"},"modified":"2023-10-05T09:27:44","modified_gmt":"2023-10-05T09:27:44","slug":"darwin-eu-towards-easy-and-secure-access-to-health-data","status":"publish","type":"post","link":"https:\/\/makingpharmaindustry.it\/en\/research\/clinical-research\/darwin-eu-towards-easy-and-secure-access-to-health-data\/","title":{"rendered":"DARWIN EU: towards easy and secure access to health data"},"content":{"rendered":" \n

DARWIN EU, acronym for Data Analysis and Real World Interrogation Network<\/a>, is the new long-term project of EMA<\/a>, the European Medicines Agency. The objective is to allow all competent national authorities and European scientific committees to find health data at any time<\/strong> throughout the life of a medicinal product.<\/p> \n \n

The program was officially born in February 2022, when EMA chose the Erasmus university medical center<\/a> in Rotterdam as its service provider. Together they developed the foundations of the project, from the perspective of government structures, contract models and processes.<\/p> \n \n

The activities of the coordination center<\/h2> \n \n

Among its many functions, the coordination center<\/strong> (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.<\/p> \n \n

Regulatory decision making involves creating and expanding a catalog of observational data<\/strong> sources<\/strong> for use in drug regulation to provide a source of high-quality, validated data on drug uses, safety, and effectiveness.<\/p> \n \n

The aim is to address specific problems through the implementation of high-quality, non-interventional studies, including the development of scientific protocols<\/strong>, the interrogation of relevant data sources, and the interpretation and communication of study results.<\/p> \n \n

The CC must also provide a structure to develop and manage the network of partners<\/strong>, 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<\/a>. Only when the network is wider will EMA be able to commission studies for third parties.<\/p> \n \n

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.<\/strong><\/p> \n \n

To implement all the services necessary to generate reliable real-world evidence, several categories of studies have been established:<\/p> \n\r\n