More-EUROPA | More Effectively Using Registries to suppOrt PAtient-centered Regulatory and HTA decision-making

Summary
While randomized controlled trials (RCTs) remain the mainstay in drug development, approval, and reimbursement, the potential of real world data (RWD) to contribute to the understanding of drug effects is increasingly realized. Evidence, based on RWD – real world evidence (RWE) - can contribute significantly to the evidence to support decision making throughout all phases of (clinical) drug development, as well as improve efficiency in design and conduct of clinical trial programs.
The aim of this project is to develop, implement and establish evidentiary standards and methods to address the data and evidentiary needs of regulatory authorities and HTA bodies towards a more efficient use of RWD for the development, registration and assessment of medicinal products in Europe (More-EUROPA).
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Web resources: https://cordis.europa.eu/project/id/101095479
Start date: 01-01-2023
End date: 31-12-2027
Total budget - Public funding: 6 997 523,75 Euro - 6 997 523,00 Euro
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Original description

While randomized controlled trials (RCTs) remain the mainstay in drug development, approval, and reimbursement, the potential of real world data (RWD) to contribute to the understanding of drug effects is increasingly realized. Evidence, based on RWD – real world evidence (RWE) - can contribute significantly to the evidence to support decision making throughout all phases of (clinical) drug development, as well as improve efficiency in design and conduct of clinical trial programs.
The aim of this project is to develop, implement and establish evidentiary standards and methods to address the data and evidentiary needs of regulatory authorities and HTA bodies towards a more efficient use of RWD for the development, registration and assessment of medicinal products in Europe (More-EUROPA).

Status

SIGNED

Call topic

HORIZON-HLTH-2022-TOOL-11-02

Update Date

09-02-2023
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Horizon Europe
HORIZON.2 Global Challenges and European Industrial Competitiveness
HORIZON.2.1 Health
HORIZON.2.1.0 Cross-cutting call topics
HORIZON-HLTH-2022-TOOL-11
HORIZON-HLTH-2022-TOOL-11-02 New methods for the effective use of real-world data and/or synthetic data in regulatory decision-making and/or in health technology assessment
HORIZON.2.1.5 Tools, Technologies and Digital Solutions for Health and Care, including personalised medicine
HORIZON-HLTH-2022-TOOL-11
HORIZON-HLTH-2022-TOOL-11-02 New methods for the effective use of real-world data and/or synthetic data in regulatory decision-making and/or in health technology assessment
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