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The GetReal Initiative

Project description

Enhancing the quality and use of real-world evidence in pharmaceutical development and regulation

The Innovative Medicines Initiative (IMI) is the world’s largest public–private partnership in health, equally funded by the EU and the pharmaceutical industry. The IMI GetReal project surveyed stakeholders’ policies and perspectives on using real-world evidence (RWE) for early drug development and clinical effectiveness assessment. The EU-funded GetReal Initiative project will ensure that critical outcomes from IMI GetReal are fully exploited and sustainable in the long term. It will bring IMI GetReal partners together again with the goal of adopting the tools, methodologies and best practices from that project to enhance the generation and use of RWE in pharmaceutical development and regulation.

Objective

The GetReal Initiative brings together partners from the IMI GetReal project to drive the adoption of tools, methodologies and best practices from IMI GetReal and increase the quality of real-world evidence (RWE) generation in medicines development and regulatory/HTA processes across Europe. We will establish, in Work Package (WP) 1, a Think Tank, a number of Task Forces and a RWE Research Community. The Think Tank will consist of international thought leaders and will discuss, assesses and give recommendations on the opportunities and barriers to the generation, use and acceptability of RWE. They will act as ambassadors for the use of RWE during the project and beyond, enagaging with key stakeholder groups to drive policy debate and facilitate the uptake of the outputs of IMI GetReal and the GetReal Initiative. The GetReal Taskforces will drive the focused development of tangible solutions to the key challenges identified in IMI GetReal and the Think Tank. The initial three task forces will be: (i) Pragmatic Trials (design, operational feasibility and analysis/the GetReal PragMagic tool), (ii) network meta-analysis and benefit risk assessment (incl. the GetReal ADDIS tool) and (iii) Statistical Approaches for enriching RCTs with real-world data. The GetReal Research Community will consist of researchers and organisations active in the field of RWE generation, regulators, HTAs, physicians and patients. The Community will review and comment on any GetReal Initiative guidelines, recommendations or white papers ahead of their finalisation, will have access to all the GetReal tools and outputs, receive regular newsletters and receive invitations to attend stakeholder events. The project will also invest in long term sustainability of the GetReal Initiative and the tools on a not-for-profit basis (WP2). The project is supported by professional experienced consortium management (WP3) and an ethics work package (WP4).

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Coordinator

UNIVERSITAIR MEDISCH CENTRUM UTRECHT
Net EU contribution
€ 525 000,00
Address
Heidelberglaan 100
3584 CX Utrecht
Netherlands

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Region
West-Nederland Utrecht Utrecht
Activity type
Higher or Secondary Education Establishments
Links
Other funding
€ 430 000,00

Participants (16)