DARWIN - sporedata/researchdesigneR GitHub Wiki
General description
The Data Analysis and Real World Interrogation Network (DARWIN EU) initiative was designed to support the European Medicines Agency (EMA)'s ability to deliver real-world evidence from across Europe on diseases, patient populations, and the uses, safety, and performance of medicines, including vaccines, all through the lifecycle of a medicinal product.
The OHDSI community will collaborate with the Erasmus University Medical Center (Erasmus MC) on this initiative to provide the EMA and national competent authorities in the EU Member States access to accurate and reliable real-world evidence. As the coordination center, Erasmus MC is charged with providing timely and reliable evidence on the application, efficacy, and safety of drugs and vaccines intended for human consumption throughout the European Union (EU).
DARWIN EU will support regulatory decision-making by: • Addressing specific questions through high-quality, non-interventional studies, including developing scientific protocols, interpreting and reporting study results, and interrogating relevant data sources. • Establishing and expanding a catalog of observational data sources for regulating medicines. • Providing a source of high-quality, validated real-world data on medicines' uses, efficacy, and safety.