Real-world data is becoming increasingly important as the amount of data generation increases as does the speed of data processing. In the US, the 21st Century Cures Act was enacted in December 2016 and mandated that the Food and Drug Administration (FDA) create a framework for evaluating the use of real-world data help support the approval of new indications for already approved drugs as well as conduct or to satisfy drug post-approval study requirements. FDA published it’s Real-world Evidence Program in 2018. In the European Union, the European Medicines Agency (EMA) established a Coordination Centre for the Data Analysis and Real World Interrogation Network (DARWIN EU) project in September 2022.
The goal of DARWIN EU is described as follows:
The vision of DARWIN EU® is to give EMA and national competent authorities in EU Member States access to valid and trustworthy real-world evidence, for example on diseases, patient populations, and the use, safety and effectiveness of medicines, including vaccines, throughout the lifecycle of a medicinal product. By supporting decision-making on the development, authorisation and surveillance of medicines, a wide range of stakeholders will benefit, from patients and healthcare professionals to health technology assessment bodies and the pharmaceutical industry.
DARWIN EU will also act ultimately aim to connect with the braoder European Health Data Space (EHDS) initiative as well.
Arlett et al. (2022) note that DARWIN EU is funded by the European Commission through EU4Health initiative and long-term finances will be supported through through industry fees charged by EMA.
DARWIN EU has established a coordination center at Erasmus University Medical Center Rotterdam to on‐board data partners and to drive the conduct of studies requested by medicines regulators (and in time requested by other stakeholders). The DARWIN EU advisory board members are listed here.
What specifically will DARWIN EU do? The EMA website notes:
- establishing and expanding a catalogue of observational data sources for use in medicines regulation;
- providing a source of high-quality, validated real world data on the uses, safety and efficacy of medicines;
- addressing specific questions by carrying out high-quality, non-interventional studies, including developing scientific protocols, interrogating relevant data sources and interpreting and reporting study results.
It will be interesting to see if DARWIN EU primary role is cataloging existing information, evaluating existing data, linking together disparate data sources, or collecting new data sources. Cataloging existing data and evaluating existing data are less valuable activities–although evaluating existing data may be useful for industry to understand how regulators will evaluate the quality of different data. If DARWIN EU could link together different data sets or collect new data, however, this could be a much stronger initiative.