IHI-GREG

Overview of the project

The GREG project (“Testing, improving, and co-creating Guidance and Tools for Real World Evidence Generation and Use for Decision-Making in Europe”) is a five-year European initiative that started in May 2025. It is funded by the Innovative Health Initiative (IHI) and brings together experts from universities, industry, regulators, patient groups, and other organisations.

Objectives

  • Develop Practical Guidance and Tools: GREG aims to create, test, and share easy-to-use guidance and tools for generating and using Real-World Evidence (RWE).

  • Support Better Decision-Making: By improving how RWE is collected and used, GREG will help regulators and Health Technology Assessment (HTA) bodies make better decisions about medicines, medical devices, and combination products.

  • Collaboration: GREG is a partnership involving many different types of organisations, ensuring a wide range of expertise and perspectives.

What is Real-World Evidence (RWE)?

RWE is data collected from real-life patient experiences, outside of traditional clinical trials. This can include information from electronic health records, patient registries, and everyday healthcare settings. RWE is increasingly important in understanding how treatments work in the real world and is used to support regulatory and HTA decisions.

EUPATI’s Role in GREG

EUPATI (European Patients’ Academy on Therapeutic Innovation) is making sure that patients are at the heart of GREG’s work. Their involvement includes:

  • Training the Consortium: EUPATI will train all project partners on how to involve patients meaningfully in research and decision-making.

  • Patient Advisory Group: EUPATI will set up a group of patient experts and organisations to advise the project throughout its five years.

  • E-Learning Course: EUPATI will develop an online course to explain RWE and how patients can contribute to RWE studies, available through the EUPATI Open Classroom.

  • Lay Summaries: EUPATI will create easy-to-understand summaries of project case studies and guidelines, making the information accessible to everyone.

All of these activities are designed to ensure that GREG is truly patient-centred and that the benefits of Real-World Evidence are accessible and understandable for patients.

For more details about the project, you can visit the project website: https://ihi-greg.eu/