Public–private collaboration GREG set to strengthen real-world evidence use across Europe

A major new initiative is set to transform how real-world evidence (RWE) is generated and applied in regulatory and health technology assessment (HTA) decision-making across Europe. The GREG project – “Testing, improving, and co-creating Guidance and Tools for Real-World Evidence Generation and Use for Decision-Making in Europe” – will bring together 29 partners from academia and industry in a five-year collaboration supported by the Innovative Health Initiative Joint Undertaking (IHI JU) and matched industry funding.

Launched in May 2025, GREG is a public–private initiative led by Erasmus University Medical Center, with Novo Nordisk serving as Project Lead and Sanofi as co-lead. The consortium spans academic institutions, HTA bodies, non-profit organizations, SMEs, and representatives from the pharmaceutical and medical device sectors.

“The field of RWE has been gathering much-deserved attention in recent years as RWE has the potential to generate valuable and high-quality evidence which could complement clinical trials and inform decision-making,” said Emel Mashaki Ceyhan, Industry Lead at Novo Nordisk. “This potential has not been fully reached despite the recent significant efforts and advancements in this field. Therefore, we strongly believe and remain confident that the outcomes of the GREG project will transform the way RWE is utilized in decision-making and enable its use and implementation with confidence by sponsors, to bring innovative treatments to patients faster.”

GREG aims to create, test, and disseminate practical tools and evidence-based guidance for generating and applying RWE in the development and evaluation of medicines, medical devices, and drug–device combinations. By supporting regulators and HTA bodies with high-quality, fit-for-purpose evidence, the project will enable faster and more efficient assessments, help accelerate market access for innovative healthcare solutions, and improve access to technologies and treatments that address the diverse needs of patients and health systems across Europe.

The project will follow an iterative, co-creation approach, drawing on the OMOP Common Data Model and utilizing datasets from initiatives such as the European Health Data and Evidence Network (EHDEN). Use cases relevant to regulators and HTA bodies will be mapped to identify evidence needs, barriers, and opportunities, with findings feeding into the development of a living library of RWE scenarios. Ongoing collaboration with regulatory bodies, including the European Medicines Agency, national authorities, and notified bodies, will ensure the tools and guidance developed are responsive to real-world decision-making challenges.

“As RWE needs increase, there is a clear need for alignment on the best methods, data, and tools,” added Daniel Prieto-Alhambra, Project Coordinator.

“GREG will deploy a dedicated team of experts to review existing guidelines, fill the gaps in the literature, and generate and pilot-test evidence-based guidance and tools for better RWE generation in Europe.”