Innovating Works

More-EUROPA

Financiado
More Effectively Using Registries to suppOrt PAtient-centered Regulatory and HTA...
More Effectively Using Registries to suppOrt PAtient-centered Regulatory and HTA decision-making 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. Ev... 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). ver más
31/12/2027
UNIVERSITAIR MEDIS...
7M€
Perfil tecnológico estimado
Duración del proyecto: 61 meses Fecha Inicio: 2022-11-24
Fecha Fin: 2027-12-31

Línea de financiación: concedida

El organismo HORIZON EUROPE notifico la concesión del proyecto el día 2022-11-24
Línea de financiación objetivo El proyecto se financió a través de la siguiente ayuda:
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
Cerrada hace 2 años
Presupuesto El presupuesto total del proyecto asciende a 7M€
Líder del proyecto
ACADEMISCH ZIEKENHUIS GRONINGEN No se ha especificado una descripción o un objeto social para esta compañía.
Perfil tecnológico TRL 4-5