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CORDIS - Resultados de investigaciones de la UE
CORDIS

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

CORDIS proporciona enlaces a los documentos públicos y las publicaciones de los proyectos de los programas marco HORIZONTE.

Los enlaces a los documentos y las publicaciones de los proyectos del Séptimo Programa Marco, así como los enlaces a algunos tipos de resultados específicos, como conjuntos de datos y «software», se obtienen dinámicamente de OpenAIRE .

Resultado final

Evidence needs across lifecycle (se abrirá en una nueva ventana)

Report on evidence needs defined by stakeholders across the lifecycle of medicinal products. Report contains summary of evidence needs formulated such that they can be translated to quantifiable concepts for use in desig and analyses of trials and RWD from registries.

Registries identification machine learning tool (se abrirá en una nueva ventana)

Natural language processing-powered tool for identifications of the registries and key opinion leaders based on automated systematic literature review (including, code, documentation, and methodology description)

Data collection (feasibility) (se abrirá en una nueva ventana)

report on the description of data from multiple sclerosis patients treated with rituximab and dimethyl fumarate from all contributing registries. This will, in addition to treatment information, include personal, clinical and other treatment data and be specified per country.

Dissemination and exploitation plan (se abrirá en una nueva ventana)

A report of the communication and dissemination plan will be written on the dissemination strategy towards key stakeholders to ensure an uptake of the project outcomes. The plan will include the set-up of More-EUROPA's website with content relevant for both the project members and the wider, lay-men’s audience, and will cover social media activities presentation templates and networking activities.

Registries identification guidelines (se abrirá en una nueva ventana)

Recommendations for registries identification; modelling plan for the tool development

Stakeholder kick-off (se abrirá en una nueva ventana)

A report will be written on the kick-off stakeholder conference with a project overview and appraisal of key stakeholders’ perspectives on implementing registry-based RWD/RWE in regulatory and HTA decision making.

Report on the state of the art and unmet needs (se abrirá en una nueva ventana)

Detailed document discussing the current practices of registry identification and assessment in Europe and worldwide.

Publicaciones

Safety of continuing mineralocorticoid receptor antagonist treatment in patients with heart failure with reduced ejection fraction and severe kidney disease: Data from Swedish Heart Failure Registry (se abrirá en una nueva ventana)

Autores: Federica Guidetti, Lars H. Lund, Lina Benson, Camilla Hage, Francesca Musella, Davide Stolfo, Peter G.M. Mol, Andreas J. Flammer, Frank Ruschitzka, Ulf Dahlstrom, Giuseppe M.C. Rosano, Oscar Ö. Braun, Gianluigi Savarese
Publicado en: European Journal of Heart Failure, 2023, ISSN 1879-0844
Editor: Wiley
DOI: 10.1002/ejhf.3049

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