PUBLICATIONS

Our team has proven track record of their work being relevant from a scientific and management standpoint. Amongst the publications that are publicly available, the members contributed to the following ones:

Schultze, A., Martin, I., Messina, D., Bots, S., Belitser, S., José Carreras-Martínez, J., Correcher-Martinez, E., Urchueguía-Fornes, A., Martín-Pérez, M., García-Poza, P., Villalobos, F., Pallejà-Millán, M., Alberto Bissacco, C., Segundo, E., Souverein, P., Riefolo, F., Durán, C. E., Gini, R., Sturkenboom, M., … Douglas, I. A comparison of four self-controlled study designs in an analysis of COVID-19 vaccines and myocarditis using five European databases. Vaccine, Volume 42, Issue 12, 2024, Pages 3039-3048. DOI: https://doi.org/10.1016/j.vaccine.2024.03.043.

Raethke M., van Hunsel F., Luxi N., Lieber T., Bellitto C., Mulder E., Ciccimarra F., Riefolo F., et al.
Frequency and timing of adverse reactions to COVID-19 vaccines; A multi-country cohort event monitoring study. Vaccine, Volume 42, Issue 9, 2024, Pages 2357-2369. DOI: https://doi.org/10.1016/j.vaccine.2024.03.001.

Ciccimarra F., Luxi N. Bellitto C., L’Abbate L., Raethke M., van Hunsel F., Lieber T., Mulder E., Riefolo F., Dureau-Pournin C., et al. Safety Monitoring of COVID-19 Vaccines in Persons with Prior SARS-CoV-2 Infection: A European Multi-Country Study. Vaccines 2024, 12, 241. DOI: https://doi.org/10.3390/vaccines12030241

Franz Koenig, Cécile Spiertz, Daniel Millar, Sarai Rodríguez-Navarro, Núria Machín, Ann Van Dessel, Joan Genescà, Juan M. Pericàs, Martin Posch, EU-PEARL Consortium. Current state-of-the-art and gaps in platform trials: 10 things you should know, insights from EU-PEARL. eClinicalMedicine, December 2023. DOI: https://doi.org/10.1016/j.eclinm.2023.102384 

Fabio Riefolo, Belén Castillo-Cano, Mar Martín-Pérez, Davide Messina, Roel Elbers, Dorieke Brink-Kwakkel, Felipe Villalobos, Ylenia Ingrasciotta, Patricia Garcia-Poza, Karin Swart-Polinder, Patrick Souverein, Luis Carlos Saiz, Carlo Alberto Bissacco, Leire Leache, Michele Tari, Salvatore Crisafulli, Lamiae Grimaldi, Tiago Vaz, Rosa Gini, Olaf Klungel, Elisa Martín-Merino. Effectiveness of homologous/heterologous booster COVID-19 vaccination schedules against severe illness in general population and clinical subgroups in three European countries. Vaccine Volume 41, Issue 47, 13 November 2023, Pages 7007-7018. DOI: https://doi.org/10.1016/j.vaccine.2023.10.011 

Riefolo, F., Cano, B. C., Martin, M. M., Messina, D., Elbers, R., Brink-Kwakkel, D., Villalobos, F., Ingrasciotta, Y., Garcia-Poza, P., Swart-Polinder, K., Souverein, P., Carlos Saiz, L., Alberto Bissaccco, C., Leache, L., Tari, M., Crisafulli, S., Barbieri, E., Stona, L., Garcia de Albeniz, X., … Martin Merino, E. (2023, September). Real-world-evidence on different COVID-19 vaccines combinations’ effectiveness in six electronic healthcare data sources from four pan-European countries. Poster presented at the
17th Vaccine Congress; 24-27 September 2023. Glasgow, Scotland.
Durán, C., Belitser, S., Bots, S., Riefolo, F., Messina, D., Gini, R., García-Poza, P., Martín Pérez, M., José Carreras, J., Correcher-Martínez, E., Urchueguía, A., Souverein, P., Villalobos, F., Reira-Arnau, J., Schultze, A., Douglas, I., Klungel, O., & Sturkenboom, M. (2023). Myocarditis Associated with Sars-Cov-2 Vaccines by Dose and Brand in Three European Countries Using Large Electronic Health Care Data Sources: A Self-Controlled Risk Interval Study  in the COVID-19 Vaccine Monitor Study. Poster presented at the 39th International Conference on Pharmacoepidemiology and Therapeutic Risk Management (ICPE). August 25, 2023. Halifax, Canada. 
Durán, C., Riefolo, F., Gini, R., Messina, D., García-Poza, P., Martín-Perez, M., Villalobos, F., Pallejà-Millán, M., Barbieri, E., Stona, L., Ingrasciotta, Y., José Carreras, J., Correcher-Martínez, E., Urchueguía, A., Tari, M., Lentile, V., & Sturkenboom, M. (2023). Incidence of COVID-19 Disease Severity in a Cohort of 4.4 Million Italian and Spanish Children from 6 Healthcare Databases. Poster presented at the 39th International Conference on Pharmacoepidemiology and Therapeutic Risk Management (ICPE). August 25, 2023. Halifax, Canada. 
Luxi, N., Raethke, M., Giele-Eshuis, J., Batel Marques, F., Busca, C., Morton, K., Riefolo, F., Sonderlichová, S., Thurin, N., Villalobos, F., Sturkenboom, M., & Trifirò, G. (2023). Safety of COVID-19 Vaccines Among People  with Prior History of SARS-Cov-2 Infection:  Results from the COVID-Vaccine-Monitor Cohort  Event Monitoring. Poster presented at the 39th International Conference on Pharmacoepidemiology and Therapeutic Risk Management (ICPE). August 25, 2023. Halifax, Canada. 
Gini, R., Messina, D., Aarts, W., Paoletti, O., Bartolini, C., Weibel, D., Choi, J., Cid-Royo, A., Elbers, R., Andres Vaz, T., Belitser, S., Bots, S., Riefolo, F., Plana, E., & Sturkenboom, M. (2023). Representation of Study Scripts to Improve Transparency and Efficiency in Multidatabase Distributed Vaccine Studies [1272]. Poster presented at the 39th International Conference on Pharmacoepidemiology and Therapeutic Risk Management (ICPE). August 25, 2023. Halifax, Canada. 

Yefimenko N,  Boric K, and  Di Mauro G. Quality compliance while conducting NIS studies: critical success factors assessment and the use of key performance indicators. Poster presented at the 39th International Conference on Pharmacoepidemiology and Therapeutic Risk Management (ICPE). August 25, 2023. Halifax, Canada. Access poster Access poster here.

Yefimenko N, Weinrib R, Boric K, Riefolo F, Jansen M, Weibel D. The challenges and lessons learnt from conducting COVID-19 monitoring studies through VAC4EU: coordination and management perspective. P-395. Poster presented at the 39th International Conference on Pharmacoepidemiology and Therapeutic Risk Management (ICPE). August 25, 2023. Halifax, Canada. Access poster here: 10.1002/pds.5687

Monika Raethke, Nicoletta Luxi, Gianluca Trifirò, Nicolas H. Thurin, Dirk Mentzer, Evelien De Clercq, Barbara Kovačić, Kathryn Morton, Carlos Miguel Costa Alves, Simona Sonderlichová, Felipe Villalobos, Fabio Riefolo, Florence van Hunsel, Miriam Sturkenboom. Safety monitoring of COVID-19 vaccines in multiple European countries: initial results from the COVID-19 Vaccine Monitor (CVM). Poster presented at the 39th International Conference on Pharmacoepidemiology and Therapeutic Risk Management (ICPE). August 25, 2023. Halifax, Canada. Access poster here.

Ahmadizar F, Fortuny J, Cid-Royo A, Plana E, Weinrib R, Garcia Esteban R, Boric K, Yefimenko N, Carreras JJ, Urcheguia A, Correcher-Martinez E, Mira-Iglesias A, Swart KMA, van den Berg JM, Overbeek JA, Villalonos F, Bissacco CA, Newbern C, Praet N, Willame C, Sturkenboom M. (2023). Safety of the Janssen COVID-19 vaccine (JCOVDEN) using VAC4EU European healthcare data: methods and results of the first study feasibility assessment.  P-415. Poster presented at the 39th ICPE Annual Conference; August 25, 2023. Halifax, Canada. DOI: 10.1002/pds.5687

Weibel D, De Luise C, Elbers R, van den Bor R, Martin I, Cid-Royo A, Plana E, Garcia de Albeniz Martinez X, Weinrib R, Yefimenko N, Poblador-Plou B, Marconi E, Barbieri E, Stona L, Swart KMA, Roy D, Hyeraci G, Bartolini C, Lupattelli A, Villalobos F, Kendrick K, Garg R, Rubino H, Eijkemans R, Sturkenboom M, Arana A. (October 23) Utilisation patterns of the COVID-19 mRNA vaccine (Comirnaty®) from the VAC4EU active safety surveillance study in five European countries. P-384. Poster presented at the 39th ICPE Annual Conference; August 25, 2023. Halifax, Canada. DOI: 10.1002/pds.5687

Durán, C. E., Schultze, A., Douglas, I., Bots, S., Belitser, S., Messina, D., Martin, I., Gini, R., Riefolo, F., Klungel, O., & Sturkenboom, M. (2023). Covid-Vaccine-Monitor Final Study Report for WP3 (electronic health record data) Deliverable 4.2-May 2023. DOI: 10.5281/zenodo.8280174. 
Tan, E. H., Robinson, D., Jödicke, A., Mosseveld, M., Bødkergaard, K., Reyes, C., Marconi, E., Lapi, F., Reinold, J., Verhamme, K., Pedersen, L., de Wilde, M., Far Ruiz, M., Aragòn, M., Grelaud, A., Lassalle, R., Riefolo, F., Yefimenko, N., Prieto-Alhambra, D., & Sanchez-Santos, M. T. (2023). The impact of COVID-19 on population level drug utilisation of Alendronate in five European countries: an uninterrupted time series analysis. Poster presented at the World Congress on Osteoporosis, Osteoarthritis and Musculoskeletal Diseases; May 2023. Barcelona, Spain. Poster available here.

Fariba Ahmadizar, Nicoletta Luxi, Monika Raethke, Sandor Schmikli, Fabio Riefolo, Putri Widi Saraswati, Camelia Bucsa, Alhadi Osman, Megan Liddiard, Francisco Batel Maques, Giuliana Petrelli, Simona Sonderlichová, Nicolas H. Thurin, Felipe Villalobos, Gianluca Trifirò, Miriam Sturkenboom & ilmiovaccinoCOVID19 collaborating group. Safety of COVID-19 Vaccines Among the Paediatric Population: Analysis of the European Surveillance Systems and Pivotal Clinical Trials. Drug Safety, Vol. 46, pages 575–585, (April 2023). DOI: https://doi.org/10.1007/s40264-023-01304-5 

Riefolo F, Raethke M, Luxi N, Ruijs L, Giovanazzi A, Schmitz J, Mentser D, Thurin N, Miroservic -Skvrce N, Liddiard M, Schmikili S, Klungel O, Trifirò G, Sturkenboom MCJM (2022). Covid-Vaccine-Monitor: a Cohort Event Monitoring Safety Study of COVID-19 Vaccines in Thirteen European Countries. Poster presentation – P092. Poster presented at the 21st ISoP Annual Meeting, September 2022. Verona (Italy). Available from: https://doi.org/10.1007/s40264-022-01219-7

Di Mauro G, Gini R, Mahey P,  Molero E, Weibel D,  Sturkenboom MCJM (2022). VAC4EU: a pan-European research network for collaborative post-authorization vaccine safety and benefit monitoring. Poster presentation – P245 Available from: https://doi.org/10.1007/s40264-022-01219-7

Weibel, D., van den Bor, R., Elbers, R., Plana, E., Garcia de Albeniz, X., Weinrib, R., Yefimenko, N., Haugh, M., Poblador Plou, B., Bianchini, E., Barbieri, E., Stona, L., Swart-Polinder, Roy, D., Hyeraci, G., Bartolini, C., Lupattelli, A., Villalobos, F., de Luise, C., … Arana, A. (2022, August). VAC4EU active safety surveillance study of the BNT162b2 COVID-19 vaccine in four European countries: study design and first results. Poster presented at the 2022 ICPE Conference; August 30, 2022. Copenhagen, Denmark. [abstract] Pharmacoepidemiol Drug Saf. 2022 Sep 23; 31(S2):627-8. Available from: https://doi.org/10.1002/pds.551

Natasha Yefimenko, Fabio Riefolo, Katica Boric, Gianmarco Di Mauro, Eva Molero. Conducting observational multi-country studies for regulatory decision making during COVID-19 pandemic: the strategic role of the scientific study manager. Poster presented at the 2022 ICPE Conference; August 30, 2022. Copenhagen, Denmark. [abstract] Pharmacoepidemiol Drug Saf. 2022 Sep 23; 31(S2):627-8. Available from: https://doi.org/10.1002/pds.551

Luxi, N; Raethke, M; Ruijs, L; Schmikli, S; Riefolo, F; Trifiro, G;  Sturkenboom, MCJM (2022). Covid-19 Vaccine Monitor: Interim Study Report for Cohort Event Monitoring of vaccinated persons. Zenodo DOI 10.5281/zenodo.6629550

Cash-Gibson L, Pericàs JM, Spiertz C, van de Ketterij E, Molero E, Patalano F, Kalra D, Ussi A, Van Dessel A, Genescà J, EU-PEARL: Changing the paradigm of clinical trials in Europe, European Journal of Public Health, Volume 31, Issue Supplement_3, October 2021. DOI: 10.1093/ckab165.657/6406328

Stamm T, Bott N, Thwaites R, Mosor E, Andrews MR, Borgdorff J, Cossio-Gil Y, de Portu S, Ferrante M, Fischer F, Hameed F, Hazelzet J, Hopkins D, Kalra D, Metcalfe T, Molero E, Newson R, Patalano F, Prasser F, Rose M, Lindskov Sachs M, Soderberg J, Strammiello V, van de Poll L, Styliadou M. Building a Value-Based Care Infrastructure in Europe: The Health Outcomes Observatory, NEJM Catalyst Innovations in Care Delivery, June 2021. DOI: 10.1056/CAT.21.0146

Riefolo F, Sortino R, Matera C, Claro E, Preda B, Vitiello S, Traserra S, Jiménez M, Gorostiza P. Rational Design of Photochromic Analogues of Tricyclic Drugs in Journal of Medicinal Chemistry 2021 64 (13), 9259-9270, June 2021 DOI: 10.1021/acs.jmedchem.1c00504

Cavaller-Bellaubi M, Faulkner S, Teixeira B, Boudes M, Molero E, Brooke N, McKeaveney L, Southerton J, Vicente MJ, Bertelsen N, García-Burgos J, Pirard V, Reid K, Ferrer E. Sustaining Meaningful Patient Engagement Across the Lifecycle of Medicines: A Roadmap for Action in Therapeutic Innovation & Regulatory Science (2021), May 2021 DOI:10.1007/s43441-021-00282-z

Barbero-Castillo A, Riefolo F, Matera C, Caldas-Martínez S, Mateos-Aparicio P, Weinert J.F., Garrido-Charles A, Claro E, Sanchez-Vives M.V., Gorostiza P. Control of Brain State Transitions with a Photoswitchable Muscarinic Agonist in Advanced Science, May 2021 DOI: 10.1002/advs.202005027

Matera C, Flammini L, Riefolo F, Domenichini G, De Amici M, Barocelli E, Dallanoce C, Bertoni S. Novel analgesic agents obtained by molecular hybridization of orthosteric and allosteric ligands in European Journal of Pharmacology Volume 876, March 2020 DOI: 10.1016/j.ejphar.2020.173061

Riefolo F, Matera C, Garrido-Charles A, Gomila A. M. J., Sortino R, Agnetta L, Claro E, Masgrau R, Holzgrabe U, Batlle M, Decker M, Guasch E, Gorostiza P. Optical Control of Cardiac Function with a Photoswitchable Muscarinic Agonist in Journal of the American Chemical Society 2019 141 (18), 7628-7636, April 2019 DOI: 10.1021/jacs.9b03505

Agnetta L, Bermudez M, Riefolo F, Matera C, Claro E, Messerer R, Littmann T, Wolber G, Holzgrabe U,Decker M. Fluorination of Photoswitchable Muscarinic Agonists Tunes Receptor Pharmacology and Photochromic Properties in Journal of Medicinal Chemistry 2019 62 (6), 3009-3020, March 2019 DOI: 10.1021/acs.jmedchem.8b01822

Lovestone S, EMIF Consortium. The European medical information framework: A novel ecosystem for sharing healthcare data across Europe. Learn Health Sys. 2019; e10214. DOI: 10.1002/lrh2.10214.

N. Yefimenko, E. Molero, D. Prieto-Alhambra, L. Pedersen, F. Lapi, K. Verhamme, M. De Ridder, P. Rijnbeek, C. Giaquinto, J. van der Lei (2019). Real world evidence multi-database research in Europe; The EU-ADR Alliance. Poster presentation at ISPE 2019.

E. Molero, C. Díaz, F. Sanz, J. L. Oliveira, G. Trifirò, A. Fourrier-Réglat, M. Molokhia, L. Pedersen, S. Boyer, L. Scotti, R. Gini, R. Herings, C. Giaquinto, M. I. Loza, G. Mazzaglia, J. van der Lei, M. Sturkenboom, on behalf of the EU-ADR consortium (2012). The EU-ADR Alliance: A federated collaborative framework for drug safety studies. Poster presentation at ISPE 2012.

Dalgleish R, Molero E, Kidd R, Jansen M, Past D, Robl A, Mons B, Diaz C, Mons A, Brookes AJ. Solving bottlenecks in data sharing in the life sciences. Human Mutation. 2012; 33: 1494-1496; DOI: 10.1002/humu.22123

 

“The important thing is not to stop questioning; never lose a holy curiosity.”

ALBERT EINSTEIN