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
Programme(s)
Funding Scheme
RIA - Research and Innovation action
Coordinator
9713 GZ Groningen
Netherlands
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Participants (13)
6525 GA Nijmegen
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17177 Stockholm
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20123 Milano
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10117 Berlin
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1649-003 Lisboa
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1083 HN Amsterdam
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The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
75014 Paris
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75017 Paris
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The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
751 05 Uppsala
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2333AA Leiden
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75006 Paris
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1030 Bruxelles
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1101CT Amsterdam
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