A major new initiative aimed at transforming how Real-World Evidence (RWE) informs healthcare decision-making across Europe has officially launched. The GREG project—Testing, improving, and co-creating Guidance and Tools for Real World Evidence Generation and Use for Decision-Making in Europe—represents a significant advancement in how medical products are evaluated and brought to market.
The five-year initiative, which commenced on May 1, 2025, brings together 29 partner organizations from 15 countries in a public-private partnership supported by the Innovative Health Initiative Joint Undertaking (IHI JU). With a substantial budget of €26.2 million—€13.2 million requested from IHI funding and €13.0 million committed by industry partners—GREG aims to create a more efficient pathway for evaluating medicines, medical devices, and drug-device combinations.
Bridging the Gap Between Real-World Data and Clinical Decision-Making
Real-World Evidence, derived from the analysis of Real-World Data (RWD), provides crucial insights from sources outside traditional clinical trials, including hospital data and electronic health records. The GREG initiative seeks to standardize and optimize how this evidence is generated and utilized across Europe.
"As RWE needs increase, there is a clear need for alignment on the best methods, data, and tools for the generation and use of this evidence to inform the development and evaluation of medicines and devices," explains Daniel Prieto Alhambra, Project Coordinator from Erasmus University Medical Center. "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."
The initiative's ultimate goal is to support better regulatory and Health Technology Assessment (HTA) decision-making, potentially accelerating market entry for valuable medical products while improving access to healthcare technologies that meet both patient needs and the requirements of diverse European healthcare systems.
Cardiovascular Focus and Patient-Centered Approach
The European Society of Cardiology (ESC), a key partner in the GREG initiative, will spearhead efforts to engage patients, analyze data through federated methods, and promote a patient-centered approach to RWE generation.
Prof. Lars Wallentin, ESC EuroHeart Executive Committee Chair, highlighted the potential impact: "By creating new tools for federated analyses, the GREG project will significantly improve our ability to gather crucial data on the quality of care and develop new treatment strategies for patients with cardiovascular diseases. By working in this project, we aim to make a real difference in the lives of patients and help clinicians provide better care."
Methodological Innovation and Data Standardization
The GREG initiative will employ an iterative approach to develop, test, and disseminate guidance and tools throughout the project lifecycle. This methodology will utilize the Observational Medical Outcomes Partnership (OMOP) Common Data Model and leverage resources from the European Health Data and Evidence Network (EHDEN) Foundation and other datasets.
This approach will enable engagement with key European data partners to test proposed methods, tools, and guidance, ensuring that the initiative's outputs are practical and applicable across different healthcare contexts.
Regulatory and HTA Use Cases
A critical component of the GREG initiative involves reviewing regulatory and HTA use cases to identify relevant topics, needs, and barriers. This process will facilitate consistent learning and support the development of practical guidance and tools.
The project will create a living library of use cases highlighting scenarios where RWE plays a crucial role in regulatory and HTA processes. This effort will involve collaboration with the European Medicines Agency, National Competent Authorities, Notified Bodies, and relevant industry stakeholders.
Collaborative Framework for European Healthcare Advancement
The GREG initiative represents a significant step forward in establishing a collaborative framework for advancing RWE practices across Europe. By bringing together diverse stakeholders—including academic institutions, regulatory bodies, industry partners, and patient representatives—the project aims to create a more harmonized approach to utilizing real-world data in healthcare decision-making.
As the initiative progresses over its five-year timeline, it is expected to deliver tangible tools and guidance that will shape how medicines and medical devices are evaluated and brought to market throughout Europe, potentially transforming patient care and healthcare delivery systems.
The launch of GREG marks the beginning of what project leaders describe as "an exciting journey to revolutionize Real-World Evidence practices across Europe," with updates on advancements to be shared as the initiative progresses.
