More Effectively Using Registries to suppOrt PAtient-centered Regulatory and HTA decision-making
HealthHORIZON-RIAID: 101095479
EC Contribution
€69,975
Consortium Size
15 orgs
Start Year
2023
▶Summary
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).
Consortium (15)
🇳🇱 ACADEMISCH ZIEKENHUIS GRONINGENNL
coordinator🇩🇪 CHARITE - UNIVERSITAETSMEDIZIN BERLINDE
partner🇳🇱 CRITICAL PATH INSTITUTE STICHTINGNL
partner🇫🇷 EURORDIS - RARE DISEASES EUROPEFR
partner🇵🇹 Faculdade de Farmácia da Universidade de LisboaPT
partner🇳🇱 IQVIA SOLUTIONS B.V.NL
partner🇸🇪 KAROLINSKA INSTITUTETSE
partner🇫🇷 QUINTENFR
partner🇫🇷 QUINTEN HEALTHFR
partner🇳🇱 STICHTING DUTCH INSTITUTE FOR CLINICAL AUDITINGNL
partner🇳🇱 STICHTING RADBOUD UNIVERSITAIR MEDISCH CENTRUMNL
partner🇧🇪 THE EUROPEAN MULTIPLE SCLEROSIS PLATFORM AISBLBE
partner🇮🇹 UNIVERSITA CATTOLICA DEL SACRO CUOREIT
partner🇫🇷 UNIVERSITE PARIS CITEFR
partner🇸🇪 UPPSALA UNIVERSITETSE
partnerProject Results (37)
Source: CORDIS, the EU research results database.
▶Publications (29)
An AI powered tool to identify and assess fit-for-use registries for real-world evidence
European Drug Utilization Conference 2025· 2025
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
Associations between cardiac resynchronization therapy and clinical outcomes according to the atrial fibrillation status in patients with heart failure with reduced ejection fraction
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
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
Ailema González-Ortiz, Paul Hjemdahl, Faizan Mazhar, Alessandro Bosi, Anne-Laure Faucon, Gianluigi Savarese, Lars H Lund, Juan Jesus Carrero
Decision-Making Criteria and Methods for Initiating Late-Stage Clinical Trials from a Multi-Stakeholder Perspective: A Scoping Review
· 2025
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
Decision-Making Criteria and Methods for Initiating Late-Stage Clinical Trials in Drug Development From a Multi-Stakeholder Perspective: A Scoping Review
· 2025
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
Decision‐Making Criteria and Methods for Initiating Late‐Stage Clinical Trials in Drug Development From a Multi‐Stakeholder Perspective: A Scoping Review
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
European Journal of Heart Failure
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
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
European Drug Utilization Conference 2025· 2025
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
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
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
On the Concepts, Methods, and Use of “Probability of Success” for Drug Development Decision‐Making: A Scoping Review
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.
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
Diogo Almeida; Diana Mandslay; Peter G. M. Mol; Bruno Sepodes; Carla Torre
RWD16 An AI-Powered Tool to Identify and Assess Fit-for-Use Registries for Drug Development and Evaluation
Ghinwa Y. Hayek, Boris Kopin, Sonia Zebachi, Gaëtan Pinon, Basile Ferry, Elisabeth Bakker, Alexandre Macquin, Sieta de Vries, Peter GM. Mol, Billy Amzal
Stakeholders’ Perspectives Toward the Use of Patient Registry Data for Decision-Making on Medicines: A Cross-Sectional Survey
Fabian Windfuhr; Sieta T. de Vries; Maria Melinder; Tanja Dahlqvist; Diogo Almeida; Bruno Sepodes; Carla Torre; Björn Wettermark; Peter G. M. Mol
Timing of Cardiac Resynchronization Therapy Following Stable Medical Therapy in Patients With Heart Failure
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
Withdrawal of Guideline-Directed Medical Therapy in Patients With Heart Failure and Improved Ejection Fraction
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
Lung Cancer
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
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
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
Criteria and Methods Applied to Decision-Making to Embark on Late-Stage Clinical Trials With a Multi-Stakeholder Perspective
Value in HealthDOI
C. Jiang, J.Tanniou, B. Amzal
Eligibility for omecamtiv mecarbil in a real-world heart failure population: Data from the Swedish Heart Failure Registry
PLoS ONEDOI
Lindberg F, Øigaard N, Metra M, Rosano GMC, Dahlström U, Mol P, Hage C, Lund LH, Savarese G.
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
European Heart Journal - Cardiovascular PharmacotherapyDOI
Becher PM, Savarese G, Benson L, Dahlström U, Karlström P, Mol PGM, Metra M, Bhatt DL, Pitt B, Lund LH.
Eligibility for vericiguat in a real-world heart failure population according to trial, guideline and label criteria: Data from the Swedish Heart Failure Registry
European Journal of Heart FailureDOI
Nguyen NV, Lindberg F, Benson L, Ferrannini G, Imbalzano E, Mol PGM, Dahlström U, Rosano GMC, Ezekowitz J, Butler J, Lund LH, Savarese G.
Ethics practices associated with reusing health data: An assessment of patient registries
medRxivDOI
Olmo van den Akker, Susanne Stark, Daniel Strech
Existing Automated Tools to Assist Evidence Generation and Better Qualification of Registries and Real-World Data: A Systematic Review From the More-EUROPA Project
Value in HealthDOI
S. Zebachi, J. Moreira, J. Tanniou, P. Godbillot, P. Tang, B. Amzal
Existing Automated Tools to Assist Evidence Generation and Better Qualification of Registries and Real-World Data: A Systematic Review From the More-EUROPA Project
Value in HealthDOI
P. Godbillot, P. Tang, J. Moreira, J. Tanniou, S. Zebachi, B. Amzal
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
European Heart Journal - Cardiovascular PharmacotherapyDOI
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
Leveraging patient experience data to guide medicines development, regulation, access decisions and clinical care in the EU
Frontiers in MedicineDOI
Almeida D, Umuhire D, Gonzalez-Quevedo R, António A, Burgos JG, Verpillat P, Bere N, Sepodes B, Torre C.
Sex differences in the prognostic role of achieving target doses of heart failure medications: Data from the Swedish Heart Failure Registry
European Journal of Heart FailureDOI
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
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
Value in HealthDOI
J. Moreira, J. Tanniou, P. Tang, P. Godbillot, F.Ahrens, B. Amzal
▶Deliverables (7)
Documents, reports
Documents, reports
Documents, reports
Documents, reports
Documents, reports
Documents, reports
Documents, reports
▶Other Results (1)
Periodic Reporting for period 1 - More-EUROPA (More Effectively Using Registries to suppOrt PAtient-centered Regulatory and HTA decision-making)