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CORDIS - EU research results
CORDIS

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

Project description

Setting standards for real-world evidence in the medicinal decision-making process

Real-world data (RWD) has the potential to contribute to the understanding of drug effects alongside clinical trials. The evidence provided by RWD regarding the health status of patients has long been overlooked. However, the development of artificial intelligence techniques and the high costs and limitations of conventional clinical trials have urged the EU-funded More-EUROPA project to consider RWD in the process of clinical drug development, approval and reimbursement. The consortium focuses on patient registries as a type of RWD and aims to formulate methodologies and standards to establish these data as evidence for the regulatory approval and health technology assessment of medicinal products in Europe.

Objective

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).

Programme(s)

Multi-annual funding programmes that define the EU’s priorities for research and innovation.

Topic(s)

Calls for proposals are divided into topics. A topic defines a specific subject or area for which applicants can submit proposals. The description of a topic comprises its specific scope and the expected impact of the funded project.

Funding Scheme

Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.

HORIZON-RIA - HORIZON Research and Innovation Actions

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Call for proposal

Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.

(opens in new window) HORIZON-HLTH-2022-TOOL-11

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Coordinator

ACADEMISCH ZIEKENHUIS GRONINGEN
Net EU contribution

Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.

€ 1 027 142,50
Address
HANZEPLEIN 1
9713 GZ Groningen
Netherlands

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Activity type
Higher or Secondary Education Establishments
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Total cost

The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.

€ 1 027 142,50

Participants (14)

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