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).
Fields of science
Keywords
Programme(s)
Funding Scheme
HORIZON-RIA - HORIZON Research and Innovation ActionsCoordinator
9713 GZ Groningen
Netherlands
See on map
Participants (14)
6525 GA Nijmegen
See on map
17177 Stockholm
See on map
20123 Milano
See on map
10117 Berlin
See on map
1649-003 Lisboa
See on map
1083 HN Amsterdam
See on map
The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
75014 Paris
See on map
75017 Paris
See on map
The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
751 05 Uppsala
See on map
2333AA Leiden
See on map
75006 Paris
See on map
1030 Bruxelles / Brussel
See on map
1101CT Amsterdam
See on map
75017 PARIS
See on map
The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.