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
Recommendations for data volume and quality assessment, including key questions to answer, recommended statistical and machine learning tools
Study on heart failure treatments (opens in new window)Report on the effectiveness/safety of various heart failure treatments. This will include the presentation/publication of the results of the analyses testing the associations novel HF medications and mortality/morbidity and onset of common safety issues.
Online training materials (opens in new window)Online training materials will be made available on CORDIS that include videos, interactive presentations, and quizzes, as well as a manual for the use of the machine learning-powered registry screening tool.
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.
KI-Trials-App (opens in new window)Report on the development and validation of the open access trial design KI-Trials-App. The app will allow users to specify combinations of inclusion and exclusion criteria, and to receive back numbers for proportion of patients eligible, and event rates. The report will present the steps taken in the development and validation and the results.
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.
Framework early-stage evidence (opens in new window)Framework to assess level of evidence needed for exploratory development decisions. Framework includes exploratory development process steps, key decision points and proposed metrics that express uncertainty in decision making, that can be used in guide trial design and use of RWD registry data.
Patient considerations (opens in new window)Report about patient relevant information and current practices. The report will present the results of the conducted mixed method research. The current practices regarding the assessment of information from patients (PROMs, demographic information) in the included registries will be presented, as well as patients' perspectives toward these results and possible lacking relevant PROs. The report will also include an advise about PROs in the registries.
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.
SWOTs themes for RWD decision-making (opens in new window)Report on the Strengths, Weaknesses, Opportunities and Threats (SWOTs) of using RWD in regulatory/HTA decision making. The report presents the results from a systematic search of literature and policies as well as interviews with relevant patient/stakeholder groups.
Representativeness of registries (opens in new window)A report about the representativeness of patients in registries. The report will document on the assessment of: - the representativeness of patients enrolled in RCTs vs. the disease registries used in this project and other RWD- the application of in- and exclusion criteria of RCTs to disease registries - the influence of registries' selection criteria to other RWD sources - associations between the representativeness and characteristics of the registries- where possible, whether the drop-out rates are higher among specific groups.
Data quality standards (opens in new window)Development of an evidence-base for data quality/density/completeness for RWE in multiple sclerosis. Data quality indicators will be identified and an assessment of data quality and quantity across several MS registries will be created.
Network meta-analysis (opens in new window)Report on the network meta-analysis: Relative cost-effectiveness of new heart failure drugs. This will include the presentation/publication of the results regarding the comparison novel/more tradition HF medications in terms of cost/effectiveness.
A More-EUROPA dedicated public website will be launched.
A pilot on how to extract the minimal dataset, focusing on unstructured patient data and a test of the validity of data gathered by this new innovative technique. Data mining techniques will be further explored and compared to existing registry data.
Determine the minimal dataset necessary for RWE for HTA. The content of a minimal dataset will be identified per disease group and compared to an expanded dataset as described per available register. Minimal datasets will be used to compare RCTs and RWE effects.
Publications
Author(s):
Diogo Almeida; Diana Mandslay; Peter G. M. Mol; Bruno Sepodes; Carla Torre
Published in:
BioDrugs, 2025, ISSN 1179-190X
Publisher:
Springer Nature Link
DOI:
10.1007/S40259-025-00737-X
Author(s):
Alessandro Villaschi, Christian Basile, Lina Benson, Paolo Gatti, William T. Abraham, Michael Böhm, Biykem Bozkurt, Javed Butler, Gianluigi Condorelli, Cecilia Linde, Marco Metra, Wilfried Mullens, Peter Mol, Shelley Zieroth, Raffaele Scorza, Lars H. Lund, Fredrik Gadler, Gianluigi Savarese
Published in:
JACC: Heart Failure, Issue 13, 2025, ISSN 2213-1779
Publisher:
Elsevier BV
DOI:
10.1016/J.JCHF.2025.102515
Author(s):
Markus Wallner, Mattia Emanuele Biber, Davide Stolfo, Gianfranco Sinagra, Lina Benson, Ulf Dahlström, Soffia Gudbjörnsdottir, Francesco Cosentino, Peter G M Mol, Giuseppe M C Rosano, aved Butler, Marco Metra, MD, Lars H Lund, Giulia Ferrannini, Gianluigi
Published in:
European Heart Journal - Cardiovascular Pharmacotherapy, ISSN 2055-6845
Publisher:
Oxford
DOI:
10.1093/EHJCVP/PVAE026
Author(s):
Renzo Laborante, Valeria Valente, Lina Benson, Paolo Gatti, Christian Basile, Alessandro Villaschi, Peter Moritz Becher, Domenico D’Amario, Carin Corovic-Cabrera, Fredrik Gadler, Gianluigi Savarese, Raffaele Scorza
Published in:
Europace, Issue 27, 2025, ISSN 1099-5129
Publisher:
Oxford University Press (OUP)
DOI:
10.1093/EUROPACE/EUAF296
Author(s):
Fabian Windfuhr; Sieta T. de Vries; Maria Melinder; Tanja Dahlqvist; Diogo Almeida; Bruno Sepodes; Carla Torre; Björn Wettermark; Peter G. M. Mol
Published in:
Drug Safety, 2025, ISSN 1179-1942
Publisher:
Springer Nature Link
DOI:
10.1007/S40264-025-01528-7
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
Author(s):
Olmo R. van den Akker; Susanne Stark; Daniel Strech
Published in:
BMC Medicine, 2024, ISSN 1741-7015
Publisher:
BioMed Central
DOI:
10.1186/S12916-024-03799-W
Author(s):
Nguyen NV, Lindberg F, Benson L, Ferrannini G, Imbalzano E, Mol PGM, Dahlström U, Rosano GMC, Ezekowitz J, Butler J, Lund LH, Savarese G.
Published in:
European Journal of Heart Failure, ISSN 1879-0844
Publisher:
Wiley
DOI:
10.1002/EJHF.2939
Author(s):
Geeske F Grit; Esmée van Geffen; Ruben Malmberg; Roelof van Leeuwen; Stefan Böhringer; Hans JM Smit; Pepijn Brocken; Job FH Eijsink; Esther Dronkers; Pim Gal; Eva Jaarsma; Regine JHM van Drie-Pierik; Anne MP Eldering-Heldens; AN Machteld Wymenga; Peter GM Mol; Juliëtte Zwaveling; Doranne Hilarius
Published in:
Lung Cancer, 2024, ISSN 0169-5002
Publisher:
Elsevier BV
DOI:
10.1016/J.LUNGCAN.2024.107950
Author(s):
Ghinwa Y. Hayek, Boris Kopin, Sonia Zebachi, Gaëtan Pinon, Basile Ferry, Elisabeth Bakker, Alexandre Macquin, Sieta de Vries, Peter GM. Mol, Billy Amzal
Published in:
Value in Health, Issue 28, 2025, ISSN 1098-3015
Publisher:
Elsevier BV
DOI:
10.1016/J.JVAL.2025.09.2766
Author(s):
Cetinyurek-Yavuz, A.; Fayyad, M.B.N.; Jiang, Ce; Brion Bouvier, F.; Beji, C.; Zebachi, S.; Hayek, G.Y.; Amzal, B.; Porcher, R.; Tanniou, J.; Roes, K.C.B.; Rodwell, L.; Rodwell, L.
Published in:
Clinical Pharmacology &Therapeutics, 2025, ISSN 1532-6535
Publisher:
Wiley
DOI:
10.1002/CPT.3571
Author(s):
Ailema González-Ortiz, Paul Hjemdahl, Faizan Mazhar, Alessandro Bosi, Anne-Laure Faucon, Gianluigi Savarese, Lars H Lund, Juan Jesus Carrero
Published in:
European Heart Journal - Quality of Care and Clinical Outcomes, Issue 11, 2025, ISSN 2058-5225
Publisher:
Oxford University Press (OUP)
DOI:
10.1093/EHJQCCO/QCAF019
Author(s):
Lindberg F, Øigaard N, Metra M, Rosano GMC, Dahlström U, Mol P, Hage C, Lund LH, Savarese G.
Published in:
PLoS ONE, ISSN 1932-6203
Publisher:
PLOS
DOI:
10.1371/JOURNAL.PONE.0303348
Author(s):
Benedikt N. Beer; Lina Benson; Christian Basile; Benedikt Schrage; Peter Moritz Becher; Stefan Blankenberg; Paulus Kirchhof; Barna Szabó‐Söderberg; Marco Metra; Anne Lindberg; Egidio Imbalzano; Giuseppe M. C. Rosano; Patric Karlström; Peter G.M. Mol; Raffaele Scorza; Lars H. Lund; Felix Lindberg; Gianluigi Savarese
Published in:
European Journal of Heart Failure, 2025, ISSN 1388-9842
Publisher:
Elsevier BV
DOI:
10.1002/EJHF.70046
Author(s):
Almeida D, Umuhire D, Gonzalez-Quevedo R, António A, Burgos JG, Verpillat P, Bere N, Sepodes B, Torre C.
Published in:
Frontiers in Medicine, ISSN 2296-858X
Publisher:
Frontiers
DOI:
10.3389/FMED.2024.1408636
Author(s):
Amerigo Ferrari, Davide Stolfo, Alicia Uijl, Nicola Orsini, Lina Benson, Gianfranco Sinagra, Peter Mol, Sieta T. de Vries, Ulf Dahlström, Giuseppe Rosano, Lars H. Lund, Gianluigi Savarese
Published in:
European Journal of Heart Failure, ISSN 1879-0844
Publisher:
Wiley
DOI:
10.1002/EJHF.3272
Author(s):
Sonia Zebachi, Julien Tanniou, Elisabeth Bakker, Sieta T. de Vries, Rossella Di Bidino, Entela Xoxi, Anna Glaser, Gianluigi Savarese, Jan Hillert, Peter G. M. Mol, Kelly Plueschke, Billy Amzal, Ghinwa Y. Hayek, Jeverson Moreira
Published in:
Clinical Pharmacology & Therapeutics, Issue 118, 2025, ISSN 0009-9236
Publisher:
Wiley
DOI:
10.1002/CPT.3746
Author(s):
Christian Basile, Felix Lindberg, Lina Benson, Federica Guidetti, Ulf Dahlström, Massimo Francesco Piepoli, Peter Mol, Raffaele Scorza, Aldo Pietro Maggioni, Lars H. Lund, Gianluigi Savarese
Published in:
Circulation, Issue 151, 2025, ISSN 0009-7322
Publisher:
Ovid Technologies (Wolters Kluwer Health)
DOI:
10.1161/CIRCULATIONAHA.124.072855
Author(s):
Becher PM, Savarese G, Benson L, Dahlström U, Karlström P, Mol PGM, Metra M, Bhatt DL, Pitt B, Lund LH.
Published in:
European Heart Journal - Cardiovascular Pharmacotherapy, ISSN 2055-6845
Publisher:
Oxford
DOI:
10.1093/EHJCVP/PVAD012
Author(s):
Ce Jiang, Céline Beji, Sonia Zebachi, Ghinwa Y. Hayek, Aysun Cetinyurek‐Yavuz, Muhammad Bergas N. Fayyad, Laura Rodwell, Kit C. B. Roes, Billy Amzal, Christoph Gerlinger, Raphaël Porcher, Julien Tanniou
Published in:
Clinical Pharmacology & Therapeutics, Issue 117, 2025, ISSN 0009-9236
Publisher:
Wiley
DOI:
10.1002/CPT.3566
Author(s):
Olmo van den Akker, Susanne Stark, Daniel Strech
Published in:
medRxiv, ISSN 0000-0000
Publisher:
x
DOI:
10.1101/2024.04.26.24306459
Author(s):
J. Moreira, J. Tanniou, P. Tang, P. Godbillot, F.Ahrens, B. Amzal
Published in:
Value in Health, ISSN 1098-3015
Publisher:
Blackwell Publishing Inc.
DOI:
10.1016/J.JVAL.2023.09.2150
Author(s):
C. Jiang, J.Tanniou, B. Amzal
Published in:
Value in Health, ISSN 1098-3015
Publisher:
Blackwell Publishing Inc.
DOI:
10.1016/J.JVAL.2023.09.2148
Author(s):
Ce Jiang, Céline Beji, Sonia Zebachi, Ghinwa Hayek, Aysun CetinyurekYavuz, Bergas Fayyad, Laura Rodwell, Kit C.B. Roes, Billy Amzal, Christoph Gerlinger, Raphaël Porcher, Julien Tanniou
Published in:
2025
Publisher:
PSI 2025 Conference
Author(s):
Ce Jiang, Céline Beji, Sonia Zebachi, Ghinwa Hayek, Aysun CetinyurekYavuz, Bergas Fayyad, Laura Rodwell, Kit C.B. Roes, Billy Amzal, Christoph Gerlinger, Raphaël Porcher, Julien Tanniou
Published in:
2025
Publisher:
SnB Conference
Author(s):
Ghinwa Y. Hayek, Pascal Godbillot, Coriande Clemente, Sonia Zebachi, Gaëtan Pinon, Boris Kopin, Elisabeth Bakker, Sieta T. de Vries, Peter G.M. Mol, Billy Amzal
Published in:
European Drug Utilization Conference 2025, 2025
Publisher:
European Drug Utilization Conference
Author(s):
P. Godbillot, P. Tang, J. Moreira, J. Tanniou, S. Zebachi, B. Amzal
Published in:
Value in Health, ISSN 1098-3015
Publisher:
Elsevier
DOI:
10.1016/J.JVAL.2023.09.2120
Author(s):
Sonia Zebachi, Julien Tanniou, Elisabeth Bakker, Sieta T. de Vries, Rossella di Bidino, Entela Xoxi, Anna Glaser, Gianluigi Savarese, Jan Hillert, Peter G.M. Mol, Kelly Plueschke, Ghinwa Hayek, Billy Amzal, Jeverson Moreira
Published in:
European Drug Utilization Conference 2025, 2025
Publisher:
European Drug Utilization Conference 2025
Author(s):
S. Zebachi, J. Moreira, J. Tanniou, P. Godbillot, P. Tang, B. Amzal
Published in:
Value in Health, ISSN 1098-3015
Publisher:
Blackwell Publishing Inc.
DOI:
10.1016/J.JVAL.2023.09.2089
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