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

€7M EUR

Funder	European Commission
Recipient Organization	Academisch Ziekenhuis Groningen
Country	Netherlands
Start Date	Jan 01, 2023
End Date	Dec 31, 2027
Duration	1,825 days
Number of Grantees	15
Roles	Participant; Coordinator
Data Source	European Commission
Grant ID	`101095479`

Grant 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).

All Grantees

Iqvia Solutions B.V.; Eurordis - Rare Diseases Europe; Academisch Ziekenhuis Groningen; Uppsala Universitet; Stichting Radboud Universitair Medisch Centrum; Charite - Universitaetsmedizin Berlin; Stichting Dutch Institute for Clinical Auditing; Karolinska Institutet; Universite Paris Cite; Critical Path Institute Stichting; The European Multiple Sclerosis Platform Aisbl; Faculdade de Farmácia Da Universidade de Lisboa; Quinten; Quinten Health; Universita Cattolica Del Sacro Cuore