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Workshop/Symposium

Session: Symposia & Workshops: Session 4

Scaling-up Real-World Evidence Generation for Regulators in Europe: DARWIN EU

Sunday, August 27, 2023
10:30 AM – 12:00 PM ADT
Location: MR202
Publication Number: 242
Background: The Data Analysis and Real World Interrogation Network (DARWIN EU®) was initiated in February 2022 as a federated data network generating reliable, reproducible and fast evidence to inform regulatory decision-making on the safety and effectiveness of medicines in Europe. DARWIN EU will also serve as pathfinder to the development of the European Health Data Space.

Objectives: To describe the aims, methods, and principles behind the setup of DARWIN EU® after its first year. Regulators, industry experts and researchers interested in real world evidence for regulatory purposes are encouraged to attend. During the symposium, they will learn about the logistics, first onboarded data partners, the approved catalogue of standardised analytics, the practices underpinning the programming of analytical pipelines, the first completed studies, and how DARWIN EU® aims to become transformational for the evaluation of medicines in Europe. Discussants will provide their perspectives on the utility and future challenges and opportunities of DARWIN EU when fully operational.

Description: The European Medicines Agency (Daniel Morales, Juan-Jose Abellan, and Andrej Segec) will present the need to scale-up real world evidence generation in Europe to support regulatory decision-making, the governance structure of the network, criteria for selection of data partners and choice of studies, and the classification of study types and methods to be used for standardised analyses on drug utilisation, disease epidemiology and effects of medicines.
The Erasmus Medical Centre/Oxford University (Prof. Rijnbeek, Prof. Prieto Alhambra, Prof. Verhamme, Dr. Edward Burn) will explain the logistics of the DARWIN EU ® Co-ordination Centre, the use of federated analytics using the OMOP Common Data Model, the principles of test-based development, and examples of recently developed analytical pipelines developed for descriptive epidemiology and drug utilisation studies. Finally, the aims, methods, and results from the first 4 studies commissioned during Year 1 of DARWIN EU will be briefly presented.
The panel of discussants (Robert Platt, CNODES, Canada, Montse Gabarro (Bayer), and Patrick Ryan (OHDSI)) will address the utility of the network and areas for further development from their perspectives.