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CORDIS - EU research results
CORDIS

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

CORDIS provides links to public deliverables and publications of HORIZON projects.

Links to deliverables and publications from FP7 projects, as well as links to some specific result types such as dataset and software, are dynamically retrieved from OpenAIRE .

Deliverables

Evidence needs across lifecycle (opens in new window)

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 (opens in new window)

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) (opens in new window)

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 (opens in new window)

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 (opens in new window)

Recommendations for registries identification; modelling plan for the tool development

Stakeholder kick-off (opens in new window)

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 (opens in new window)

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

Publications

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 (opens in new window)

Author(s): 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
Published in: European Journal of Heart Failure, 2023, ISSN 1879-0844
Publisher: Wiley
DOI: 10.1002/ejhf.3049

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