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Testing, improving, and co-creating Guidance and Tools for Real World Evidence Generation in Europe and use for Decision-Making in Europe: GREG

Project description

From raw data to real health decisions

A massive amount of health data is being stored by hospitals and clinics across Europe. Unfortunately, most of it can never be used because its quality varies and it is scattered. As such, this raw data rarely helps shape how new medicines or medical devices are developed. With this in mind, the EU-funded GREG project aims to build practical tools and guides to help regulators and companies use real-world data to make decisions. By working with everyone from patients to industry experts, the project will design and test new methods through real-life case studies and training programmes. The goal is to turn raw data into a way for people to get better treatments, faster.

Objective

Europe generates real world health data (RWD) that has the potential to inform the development and evaluation of medicines and medical devices. However, multiple barriers remain that limit the access, analysis, interpretation, and use of RWD, hampering its use. Additionally, the limited uptake of existing guidelines for the generation and use of real world evidence (RWE) adds complexity in the use of RWD to inform decision making. The GREG consortium will leverage the learnings of previous and ongoing key RWE initiatives to fill these gaps by generating, pilot-testing, and disseminating evidence-based guidance and tools for the use of RWE to inform the development and evaluation of medicines, medical devices, and combinations.

To achieve these goals, we will work with key stakeholders to iteratively test and improve our guidance and tools, backed by case studies from previous successful and unsuccessful examples.

We will engage with the most relevant European RWE initiatives and access the largest network of RWD partners in Europe, namely the European Health Data and Evidence Network (EHDEN) through our partner, the EHDEN Foundation. Additionally, we will provide multi-stakeholder gatherings (including patient and public representatives) to promote the dissemination, adoption, and implementation of RWE for decision-making in Europe.

Our public and private partners will co-create use cases working closely with key regulatory and health technology experts in bespoke fora. These will be used initially to evaluate existing guidelines, and later to pilot-test the GREG guidance and tools.

Our outputs will include training for all involved stakeholders on the use of our guidance and tools, and practical templates to facilitate regulatory and health technology/payer submissions. Together, these will accelerate access to better medicines and medical devices for European citizens.

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Programme(s)

Topic(s)

Funding Scheme

HORIZON-JU-RIA - HORIZON JU Research and Innovation Actions

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Call for proposal

(opens in new window) HORIZON-JU-IHI-2024-06-two-stage

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Coordinator

ERASMUS UNIVERSITAIR MEDISCH CENTRUM ROTTERDAM
Net EU contribution
€ 3 532 316,66
Address
DR MOLEWATERPLEIN 40
3015 GD Rotterdam
Netherlands
Activity type
Higher or Secondary Education Establishments
Links
Total cost
€ 4 702 316,66

Participants (32)

Partners (24)