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

Livrables

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

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)

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

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

Recommendations for registries identification; modelling plan for the tool development

Stakeholder kick-off

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

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

Publications

Real-World Data Included in Post-authorisation Measures: A Case Study of Approved Advanced Therapy Medicinal Products in the European Union between 2013 and 2024

Auteurs: Diogo Almeida; Diana Mandslay; Peter G. M. Mol; Bruno Sepodes; Carla Torre
Publié dans: BioDrugs, 2025, ISSN 1179-190X
Éditeur: Springer Nature Link
DOI: 10.1007/S40259-025-00737-X

Timing of Cardiac Resynchronization Therapy Following Stable Medical Therapy in Patients With Heart Failure

Auteurs: 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
Publié dans: JACC: Heart Failure, Numéro 13, 2025, ISSN 2213-1779
Éditeur: Elsevier BV
DOI: 10.1016/J.JCHF.2025.102515

Glucagon-like peptide-1 receptor agonists use and associations with outcomes in heart failure and type 2 diabetes. Data from the Swedish Heart Failure and Swedish National Diabetes Registries

Auteurs: 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
Publié dans: European Heart Journal - Cardiovascular Pharmacotherapy, ISSN 2055-6845
Éditeur: Oxford
DOI: 10.1093/EHJCVP/PVAE026

Associations between cardiac resynchronization therapy and clinical outcomes according to the atrial fibrillation status in patients with heart failure with reduced ejection fraction

Auteurs: 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
Publié dans: Europace, Numéro 27, 2025, ISSN 1099-5129
Éditeur: Oxford University Press (OUP)
DOI: 10.1093/EUROPACE/EUAF296

Stakeholders’ Perspectives Toward the Use of Patient Registry Data for Decision-Making on Medicines: A Cross-Sectional Survey

Auteurs: Fabian Windfuhr; Sieta T. de Vries; Maria Melinder; Tanja Dahlqvist; Diogo Almeida; Bruno Sepodes; Carla Torre; Björn Wettermark; Peter G. M. Mol
Publié dans: Drug Safety, 2025, ISSN 1179-1942
Éditeur: Springer Nature Link
DOI: 10.1007/S40264-025-01528-7

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

Auteurs: 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
Publié dans: European Journal of Heart Failure, 2023, ISSN 1879-0844
Éditeur: Wiley
DOI: 10.1002/ejhf.3049

BMC Medicine

Auteurs: Olmo R. van den Akker; Susanne Stark; Daniel Strech
Publié dans: BMC Medicine, 2024, ISSN 1741-7015
Éditeur: BioMed Central
DOI: 10.1186/S12916-024-03799-W

Eligibility for vericiguat in a real-world heart failure population according to trial, guideline and label criteria: Data from the Swedish Heart Failure Registry

Auteurs: Nguyen NV, Lindberg F, Benson L, Ferrannini G, Imbalzano E, Mol PGM, Dahlström U, Rosano GMC, Ezekowitz J, Butler J, Lund LH, Savarese G.
Publié dans: European Journal of Heart Failure, ISSN 1879-0844
Éditeur: Wiley
DOI: 10.1002/EJHF.2939

Lung Cancer

Auteurs: 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
Publié dans: Lung Cancer, 2024, ISSN 0169-5002
Éditeur: Elsevier BV
DOI: 10.1016/J.LUNGCAN.2024.107950

RWD16 An AI-Powered Tool to Identify and Assess Fit-for-Use Registries for Drug Development and Evaluation

Auteurs: Ghinwa Y. Hayek, Boris Kopin, Sonia Zebachi, Gaëtan Pinon, Basile Ferry, Elisabeth Bakker, Alexandre Macquin, Sieta de Vries, Peter GM. Mol, Billy Amzal
Publié dans: Value in Health, Numéro 28, 2025, ISSN 1098-3015
Éditeur: Elsevier BV
DOI: 10.1016/J.JVAL.2025.09.2766

On the Concepts, Methods, and Use of “Probability of Success” for Drug Development Decision‐Making: A Scoping Review

Auteurs: 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.
Publié dans: Clinical Pharmacology &Therapeutics, 2025, ISSN 1532-6535
Éditeur: Wiley
DOI: 10.1002/CPT.3571

Characteristics, use of guideline–recommended medical therapies and clinical outcomes of patients with heart failure not enrolled in a quality registry: a comparison with the Swedish Heart Failure Registry

Auteurs: Ailema González-Ortiz, Paul Hjemdahl, Faizan Mazhar, Alessandro Bosi, Anne-Laure Faucon, Gianluigi Savarese, Lars H Lund, Juan Jesus Carrero
Publié dans: European Heart Journal - Quality of Care and Clinical Outcomes, Numéro 11, 2025, ISSN 2058-5225
Éditeur: Oxford University Press (OUP)
DOI: 10.1093/EHJQCCO/QCAF019

Eligibility for omecamtiv mecarbil in a real-world heart failure population: Data from the Swedish Heart Failure Registry

Auteurs: Lindberg F, Øigaard N, Metra M, Rosano GMC, Dahlström U, Mol P, Hage C, Lund LH, Savarese G.
Publié dans: PLoS ONE, ISSN 1932-6203
Éditeur: PLOS
DOI: 10.1371/JOURNAL.PONE.0303348

European Journal of Heart Failure

Auteurs: 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
Publié dans: European Journal of Heart Failure, 2025, ISSN 1388-9842
Éditeur: Elsevier BV
DOI: 10.1002/EJHF.70046

Leveraging patient experience data to guide medicines development, regulation, access decisions and clinical care in the EU

Auteurs: Almeida D, Umuhire D, Gonzalez-Quevedo R, António A, Burgos JG, Verpillat P, Bere N, Sepodes B, Torre C.
Publié dans: Frontiers in Medicine, ISSN 2296-858X
Éditeur: Frontiers
DOI: 10.3389/FMED.2024.1408636

Sex differences in the prognostic role of achieving target doses of heart failure medications: Data from the Swedish Heart Failure Registry

Auteurs: 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
Publié dans: European Journal of Heart Failure, ISSN 1879-0844
Éditeur: Wiley
DOI: 10.1002/EJHF.3272

Navigating the Real World: A Scoping Review of Structured Frameworks to Effectively Identify, Evaluate, and Select Real‐World Data Sources for Fit‐for‐Purpose Studies

Auteurs: 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
Publié dans: Clinical Pharmacology & Therapeutics, Numéro 118, 2025, ISSN 0009-9236
Éditeur: Wiley
DOI: 10.1002/CPT.3746

Withdrawal of Guideline-Directed Medical Therapy in Patients With Heart Failure and Improved Ejection Fraction

Auteurs: 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
Publié dans: Circulation, Numéro 151, 2025, ISSN 0009-7322
Éditeur: Ovid Technologies (Wolters Kluwer Health)
DOI: 10.1161/CIRCULATIONAHA.124.072855

Eligibility for sotagliflozin in a real-world heart failure population based on the SOLOIST-WHF trial enrolment criteria: data from the Swedish heart failure registry

Auteurs: Becher PM, Savarese G, Benson L, Dahlström U, Karlström P, Mol PGM, Metra M, Bhatt DL, Pitt B, Lund LH.
Publié dans: European Heart Journal - Cardiovascular Pharmacotherapy, ISSN 2055-6845
Éditeur: Oxford
DOI: 10.1093/EHJCVP/PVAD012

Decision‐Making Criteria and Methods for Initiating Late‐Stage Clinical Trials in Drug Development From a Multi‐Stakeholder Perspective: A Scoping Review

Auteurs: 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
Publié dans: Clinical Pharmacology & Therapeutics, Numéro 117, 2025, ISSN 0009-9236
Éditeur: Wiley
DOI: 10.1002/CPT.3566

Ethics practices associated with reusing health data: An assessment of patient registries

Auteurs: Olmo van den Akker, Susanne Stark, Daniel Strech
Publié dans: medRxiv, ISSN 0000-0000
Éditeur: x
DOI: 10.1101/2024.04.26.24306459

What Are Unmet Needs for the Use of Registries in Regulatory/HTA Decision-Making in Europe? A Survey-Based Approach From the More-EUROPA Project

Auteurs: J. Moreira, J. Tanniou, P. Tang, P. Godbillot, F.Ahrens, B. Amzal
Publié dans: Value in Health, ISSN 1098-3015
Éditeur: Blackwell Publishing Inc.
DOI: 10.1016/J.JVAL.2023.09.2150

Criteria and Methods Applied to Decision-Making to Embark on Late-Stage Clinical Trials With a Multi-Stakeholder Perspective

Auteurs: C. Jiang, J.Tanniou, B. Amzal
Publié dans: Value in Health, ISSN 1098-3015
Éditeur: Blackwell Publishing Inc.
DOI: 10.1016/J.JVAL.2023.09.2148

Decision-Making Criteria and Methods for Initiating Late-Stage Clinical Trials from a Multi-Stakeholder Perspective: A Scoping Review

Auteurs: 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
Publié dans: 2025
Éditeur: PSI 2025 Conference

Decision-Making Criteria and Methods for Initiating Late-Stage Clinical Trials in Drug Development From a Multi-Stakeholder Perspective: A Scoping Review

Auteurs: 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
Publié dans: 2025
Éditeur: SnB Conference

An AI powered tool to identify and assess fit-for-use registries for real-world evidence

Auteurs: 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
Publié dans: European Drug Utilization Conference 2025, 2025
Éditeur: European Drug Utilization Conference

Existing Automated Tools to Assist Evidence Generation and Better Qualification of Registries and Real-World Data: A Systematic Review From the More-EUROPA Project

Auteurs: P. Godbillot, P. Tang, J. Moreira, J. Tanniou, S. Zebachi, B. Amzal
Publié dans: Value in Health, ISSN 1098-3015
Éditeur: Elsevier
DOI: 10.1016/J.JVAL.2023.09.2120

Navigating the Real World: A Scoping Review of Structured Frameworks to Effectively Identify, Evaluate, and Select Real-World Data Sources for Fit-for-Purpose Studies

Auteurs: 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
Publié dans: European Drug Utilization Conference 2025, 2025
Éditeur: European Drug Utilization Conference 2025

Existing Automated Tools to Assist Evidence Generation and Better Qualification of Registries and Real-World Data: A Systematic Review From the More-EUROPA Project

Auteurs: S. Zebachi, J. Moreira, J. Tanniou, P. Godbillot, P. Tang, B. Amzal
Publié dans: Value in Health, ISSN 1098-3015
Éditeur: Blackwell Publishing Inc.
DOI: 10.1016/J.JVAL.2023.09.2089

Livrables

Publications

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