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The GetReal Initiative

Project information

Grant agreement ID: 807012

Status

Ongoing project

  • Start date

    1 June 2018

  • End date

    31 May 2020

Funded under:

H2020-EU.3.1.7.

  • Overall budget:

    € 3 100 688

  • EU contribution

    € 1 750 000

Coordinated by:

UNIVERSITAIR MEDISCH CENTRUM UTRECHT

Netherlands

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).

Coordinator

UNIVERSITAIR MEDISCH CENTRUM UTRECHT

Address

Heidelberglaan 100
3584 Cx Utrecht

Netherlands

Activity type

Higher or Secondary Education Establishments

EU Contribution

€ 525 000

Participants (15)

NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE

United Kingdom

EU Contribution

€ 220 000

L.A SANTE, EPIDEMIOLOGIE, EVALUATION ET RECHERCHE L.A.S.E.R.

France

EU Contribution

€ 210 000

ZORGINSTITUUT NEDERLAND

Netherlands

EU Contribution

€ 110 000

ACADEMISCH ZIEKENHUIS GRONINGEN

Netherlands

EU Contribution

€ 393 200

INTERNATIONAL ALLIANCE OF PATIENT'ORGANIZATIONS

United Kingdom

EU Contribution

€ 90 000

VITAL TRANSFORMATION

Belgium

EU Contribution

€ 201 800

GLAXOSMITHKLINE RESEARCH AND DEVELOPMENT LTD.

United Kingdom

Eli Lilly and Company Limited

United Kingdom

TAKEDA DEVELOPMENT CENTRE EUROPE LTD.

United Kingdom

SANOFI-AVENTIS RECHERCHE & DEVELOPPEMENT

France

AMGEN LIMITED

United Kingdom

BAYER AKTIENGESELLSCHAFT

Germany

ASTRAZENECA AB

Sweden

ASTELLAS PHARMA EUROPE BV

Netherlands

UCB BIOPHARMA SRL

Belgium

Project information

Grant agreement ID: 807012

Status

Ongoing project

  • Start date

    1 June 2018

  • End date

    31 May 2020

Funded under:

H2020-EU.3.1.7.

  • Overall budget:

    € 3 100 688

  • EU contribution

    € 1 750 000

Coordinated by:

UNIVERSITAIR MEDISCH CENTRUM UTRECHT

Netherlands