CORDIS oferuje możliwość skorzystania z odnośników do publicznie dostępnych publikacji i rezultatów projektów realizowanych w ramach programów ramowych HORYZONT.
Odnośniki do rezultatów i publikacji związanych z poszczególnymi projektami 7PR, a także odnośniki do niektórych konkretnych kategorii wyników, takich jak zbiory danych i oprogramowanie, są dynamicznie pobierane z systemu OpenAIRE .
Rezultaty
Scientific report on the lessons learned from running randomised registry trials in Sweden, and the infrastructure and supporting technology that are required, so that they can be adapted for other contexts and applied to provide results appropriate for regulatory submissions.
Recommendations for a hierarchy of clinical evidence for high-risk medical devices (odnośnik otworzy się w nowym oknie)The CORE–MD consortium will present its conclusions in summary recommendations concerning a hierarchy of types of methodologies to generate clinical evidence, as well as needs for future research and developments in EU regulatory science.
Database of studies of high-risk medical devices (odnośnik otworzy się w nowym oknie)Central database of published studies that have generated evidence on high-risk medical devices with approval for use in Europe, ordered according to the hierarchy of levels of evidence developed in WP3.
Expert advice on criteria for the regulatory evaluation of ML and AI (odnośnik otworzy się w nowym oknie)Expert advice on how machine learning and artificial intelligence high-risk implementations should be evaluated before use and after implementation from a clinical patient value perspective.
Proposals for a hierarchy of clinical study designs (odnośnik otworzy się w nowym oknie)A consensus statement for regulators concerning the scientific validity of clinical study designs for medical devices, from pilot observational studies to large randomised controlled trials and including new methodologies, ranked according to their reliability and utility.
Final report on dissemination and networking (odnośnik otworzy się w nowym oknie)A detailed report describing all the WP activities implemented from Month 19 to Month 36, such as organising meetings, conferences and webinars, participation in external events and congresses, publishing articles, conducting surveys and public consultations, etc.
Decision framework to assess the performance of high-risk medical devices (odnośnik otworzy się w nowym oknie)• Review of endpoints and methods used to assess performance of medical devices in EU registries, and potentially relevant endpoints from other data sources• Proposed framework to assess performance of medical devices, endpoints included and the methods used to combine outcomes into a single benchmark. This will include recommendations on the criteria for reliable estimation, grouping of medical devices and proposed timepoints for benchmarking.
Report on conditions on certificates by notified bodies (odnośnik otworzy się w nowym oknie)A publication with the results of EU and other experience relating to clinical evidence generation after market access.
An Ethics Charter for Innovation in Medical Devices (odnośnik otworzy się w nowym oknie)Following preparatory work by ESC and EFORT, informed by conclusions from Tasks 2.1 and 2.4 and discussions at a workshop, an Ethics Charter will be recommended to guide practice by innovators, developers, and clinicians involved in the design, feasibility and early studies, and clinical trials of new high-risk medical devices.
Scientific report on statistical methods for medical device trials (odnośnik otworzy się w nowym oknie)Expert recommendations on methods for evaluating clinical trials and studies of highrisk medical devices
Dissemination & Communication Plan (odnośnik otworzy się w nowym oknie)Definition of COREMD dissemination and communication activities providing detailed information on brand recognition target groups media synergies
Report on dissemination and networking (odnośnik otworzy się w nowym oknie)A detailed report describing all the WP activities implemented at Month 18 such as organising meetings conferences and webinars participation in external events and congresses publishing articles conducting surveys and public consultations etc
Recommendations on PROMs for conformity assessment and post-market surveillance (odnośnik otworzy się w nowym oknie)Including a literature review on disease-specific PROMS currently used, with a focus on minimally important clinical differences, sample size and follow-up intervals to enable discrimination in performance of devices, and a Core Outcome Set from the perspective of patients.
Report on study design recommendations in guidance documents for high-risk medical devices (odnośnik otworzy się w nowym oknie)Published manuscript summarising both consensus recommendations from academic consortia and professional associations, and regulatory guidance documents from international jurisdictions, concerning methodologies for clinical trials of high-risk medical devices, that were identified during the CORE-MD systematic review.
Roadmap for education and training (odnośnik otworzy się w nowym oknie)A survey on needs for clinical and methodological expertise and on needs for additional regulatory guidance perceived by NB is conducted under the auspice of Team-NB. The survey results are clustered according to overlapping topics (M12: Team NB, TÜV Süd). Based on structured dialogues among stakeholders (see D 4.3) a plan is developed for advanced training of staff NB members, scientific/clinical experts (incl. elements such as development of internship scheme, short-term sabbatical attachments with manufacturers, notified bodies, competent authorities) and a roadmap (M36, Team NB, Biomed Alliance).
Consensus recommendations on a desirable regulatory policy for paediatric high-risk medical devices (odnośnik otworzy się w nowym oknie)A report on criteria for accepting evidence for regulatory purposes from clinical studies of high-risk devices in children, when sample sizes may be small, with a discussion of methods for generating and evaluating evidence for orphan medical devices including the balance between pre- and post-market data, the need for compassionate use approvals, and priorities for methodological research.
Project handbook (odnośnik otworzy się w nowym oknie)This document presents the Project coordination aspects and the Project supporting procedures More specifically it describes the knowledge base which consists of procedures tools and information needed to manage and support the Projects activities Finally it contains three sections devoted to Quality Plan to the Risk Management Plan and to Ethical Issues
Peer-reviewed manuscripts (odnośnik otworzy się w nowym oknie)Publication of main analysis and principal secondary/sensitivity analyses.
Publication on early-phase clinical studies of high-risk medical devices (odnośnik otworzy się w nowym oknie)Report on the utility of the IDEAL recommendations for innovative medical device studies and their relevance to the framework of the MDR.
Create and maintain a project website coremdeu that will be regularly updated A mission statement will be highlighted in the homepage The web site will offer general information in English about the project its partners and H2020 Programme It will inform about events and activities of the project as well as other relevant news on project topics It will be used for dissemination towards stakeholders and the public Through it open consultations on draft recommendation from the consortium will also be conducted A search box will be an integral part of the site search functionality of the project website Google Analytics will be used to monitor the traffic of the website
Central cross-specialty repository of the design and methodology of clinical investigations for high-risk medical devices with approval for use in Europe.
Educational resources (odnośnik otworzy się w nowym oknie)Each Task in CORE-MD will create a 1-hour webinar that will be available for viewing on the project website, to summarise its findings, conclusions, and questions.
Publikacje
Autorzy:
Moons, P., Norekvål, T. M., Arbelo, E., Borregaard, B., Casadei, B., Cosyns, B., Cowie, M. R., Fitzsimons, D., Fraser, A. G., Jaarsma, T., Kirchhof, P., Mauri, J., Mindham, R., Sanders, J., Schiele, F., Torbica, A., & Zwisler, A. D.
Opublikowane w:
European Heart Journal, Numer Volume 44, Numer 36, 2023, Strona(/y) 3405-3422
Wydawca:
Oxford Academy
DOI:
10.1093/eurheartj/ehad514
Autorzy:
Siontis, G. C. M., Frenk, A., & Windecker, S.
Opublikowane w:
European Health Journal, Numer Volume 45, Numer 7, 2024, Strona(/y) 553-554
Wydawca:
Oxford University Press
DOI:
10.1093/eurheartj/ehad806
Autorzy:
Hoogervorst, L. A., Geurkink, T. H., Lübbeke, A., Buccheri, S., Schoones, J. W., Torre, M., Laricchiuta, P., Piscoi, P., Pedersen, A. B., Gale, C. P., Smith, J. A., Maggioni, A. P., James, S., Fraser, A. G., Nelissen, R. G. H. H., & Marang-van de Mheen, P. J.
Opublikowane w:
International Journal of Health Policy and Management, Numer Volume 12, Numer 1, 2023, Strona(/y) 1-11
Wydawca:
Kerman University of Medical Sciences
DOI:
10.34172/ijhpm.2023.7648
Autorzy:
Fraser AG, Nelissen RGHH, Kjærsgaard-Andersen P, Szymański P, Melvin T, Piscoi P
Opublikowane w:
EFORT Open Reviews, Numer Volume 6, Numer 10, 2021, Strona(/y) 839–849
Wydawca:
EFORT
DOI:
10.1302/2058-5241.6.210081
Autorzy:
Siontis, G. C., Frenk, A., Coles, B., Bartkowiak, J., McGovern, L., Häner, J., Tomii, D., Galea, R., Häberlin, A., Praz, F., & Windecker, S.
Opublikowane w:
2022
Wydawca:
PROSPERO
Autorzy:
Bano, A., Laimer, M., Wehrli, F., Kunzler, J., Rivero, T., Fraser, A. G., Stettler, C., Hovorka, R., & Bally, L.
Opublikowane w:
BMJ, Numer Volume 13, Numer 4, 2023
Wydawca:
BMJ
DOI:
10.1136/bmjopen-2022-070672
Autorzy:
Siontis, G. C. M., Coles, B., Häner, J. D., McGovern, L., Bartkowiak, J., Coughlan, J. J., Spirito, A., Galea, R., Haeberlin, A., Praz, F., Tomii, D., Melvin, T., Frenk, A., Byrne, R. A., Fraser, A. G., Windecker, S., & CORE-MD Investigators
Opublikowane w:
European Heart Journal, Numer Volume 43, Numer 3, 2021, Strona(/y) 161-177
Wydawca:
Oxford University Press
DOI:
10.1093/eurheartj/ehad567
Autorzy:
Hoogervorst, L. A., Geurkink, T. H., Schoones, J. W., Buccheri, S., James, S., Gale, C. P., Fraser, A. G., Nelissen, R. G. H. H., Marang-Van De Mheen, P. J., & Coordinating Research and Evidence for Medical Devices (CORE-MD) consortium
Opublikowane w:
European Heart Journal, Numer Volume 44, Numer Supplement_2, 2023
Wydawca:
Oxford University Press
DOI:
10.1093/eurheartj/ehad655.3001
Autorzy:
Guerlich, K., Patro-Golab, B., Dworakowski, P., Fraser, A. G., Kammermeier, M., Melvin, T., & Koletzko, B.
Opublikowane w:
Pediatric research, Numer Volume 95, Numer 3, 2024, Strona(/y) 615-624
Wydawca:
Springer Nature
DOI:
10.1038/s41390-023-02819-4
Autorzy:
Hoogervorst, L.
Opublikowane w:
2022
Wydawca:
OSF
Autorzy:
Siontis, G. C., Frenk, A., Coles, B., Bartkowiak, J., McGovern, L., Häner, J., Tomii, D., Galea, R., Häberlin, A., Praz, F., & Windecker, S.
Opublikowane w:
National Institute for Health and Care Research, 2022
Wydawca:
PROSPERO
Autorzy:
Wild C., Ettinger S.
Opublikowane w:
Journal of Medical Device Regulation, Numer Volume 20, Numer 2, 2023, Strona(/y) 45-56
Wydawca:
Global Regulatory Press
Autorzy:
Lübbeke, A.
Opublikowane w:
EFORT Open Reviews, Numer Volume 8, Numer 11, 2024, Strona(/y) 781-791
Wydawca:
Zenodo
DOI:
10.5281/zenodo.10623389
Autorzy:
Ren, Y., & Caiani, E. G.
Opublikowane w:
Zenodo, 2024
Wydawca:
Zenodo
DOI:
10.5281/zenodo.10864069
Autorzy:
Gibello R., Ren Y., Caiani E.G.
Opublikowane w:
European Heart Journal, Numer Volume 44, Numer Supplement_2, 2023
Wydawca:
Oxford University Press
DOI:
10.1093/eurheartj/ehad655.3024
Autorzy:
Fraser, A. G., Biasin, E., Bijnens, B., Bruining, N., Caiani, E. G., Cobbaert, K., Davies, R. H., Gilbert, S. H., Hovestadt, L., Kamenjasevic, E., Kwade, Z., McGauran, G., O'Connor, G., Vasey, B., & Rademakers, F. E.
Opublikowane w:
Expert review of medical devices, Numer Volume 20, Numer 6, 2023, Strona(/y) 467-491
Wydawca:
Taylor & Francis
DOI:
10.1080/17434440.2023.2184685
Autorzy:
Szymański, P., & Redberg, R.
Opublikowane w:
European Heart Journal, Numer Volume 45, Numer 3, 2024, Strona(/y) 178-180
Wydawca:
Oxford University Press
DOI:
10.1093/eurheartj/ehad786
Autorzy:
Schnell-Inderst, P., Kuehne, F., Holborow, R., Rochau, U., & Siebert, U.
Opublikowane w:
Value in Health, Numer Volume 25, Numer 12, 2022
Wydawca:
Elsevier Inc
DOI:
10.1016/j.jval.2022.09.1878
Autorzy:
Hoogervorst, L.
Opublikowane w:
OSG Registries, 2023
Wydawca:
OSF
DOI:
10.17605/osf.io/r87vt
Autorzy:
Guerlich, K., Bernadeta, P., Michael, K., Paulina, D., & Berthold, K.
Opublikowane w:
OSF REGISTRIES, 2023
Wydawca:
OSF
DOI:
10.17605/osf.io/uzekt
Autorzy:
Smith, J. A., Combescure C., Barea C., Lübbeke-Wolff A.
Opublikowane w:
2021
Wydawca:
OSF
DOI:
10.17605/osf.io/9bjqv
Autorzy:
Bano, A.
Opublikowane w:
Zenodo, 2025
Wydawca:
Zenodo
DOI:
10.5281/zenodo.10894441
Autorzy:
Siontis, G.
Opublikowane w:
Zenodo, 2024
Wydawca:
Zenodo
DOI:
10.5281/zenodo.10617117
Autorzy:
Chaplin, J., Rolfson, O., Jarke, H., Moons, P., Norekvål, T., & Holm Ingelsrud, L.
Opublikowane w:
National Institute for Health and Care Research, 2022
Wydawca:
PROSPERO
Autorzy:
Melvin T., Kenny D., Gewillig M., Fraser A.G.
Opublikowane w:
Pediatric Cardiology, Numer Volume 44, Numer 2, 2023, Strona(/y) 271-279
Wydawca:
Springer Nature
DOI:
10.1007/s00246-022-03029-1
Autorzy:
Ren, Y., Bertoldi, M., Fraser, A. G., & Caiani, E. G.
Opublikowane w:
Therapeutic Innovation & Regulatory Science, Numer Volume 57, Numer 3, 2023, Strona(/y) 589-602
Wydawca:
Springer Nature
DOI:
10.1007/s43441-022-00493-y
Autorzy:
López, J. A., Dobrzynska, A., Lozano, M. P. R., Parrilla, J. C. R., Epstein, D. M., & Amaro, J. A. B.
Opublikowane w:
National Institute for Health and Care Research, 2023
Wydawca:
PROSPERO
Autorzy:
Schnell-Inderst, P., Kühne, F., Rochau, U., Schmid, D., & Siebert, U.
Opublikowane w:
2022
Wydawca:
OSF
Autorzy:
Gibello, R.
Opublikowane w:
2023
Wydawca:
POLIMNI
Autorzy:
Ivan Gibanica I.
Opublikowane w:
2023
Wydawca:
GOETEBORGS UNIVERSITET
Autorzy:
Chaplin J.
Opublikowane w:
Quality of Life Research, Numer Volume 32, Supplement_2, 2023, Strona(/y) 23-220
Wydawca:
Springer Nature
DOI:
10.1007/s11136-023-03530-x
Autorzy:
Ren Y., Bertoldi M., Caiani E.G.
Opublikowane w:
European Heart Journal, Numer Volume 43, Numer Supplement_2, 2022
Wydawca:
Oxford University Press
DOI:
10.1093/eurheartj/ehac544.2842
Autorzy:
Ren Y. and Caiani E.G.
Opublikowane w:
2023 IEEE EMBS International Conference on Biomedical and Health Informatics (BHI), 2023, Strona(/y) 1-4
Wydawca:
IEEE
DOI:
10.1109/bhi58575.2023.10313402
Autorzy:
A G Fraser; R G H H Nelissen; P Kjærsgaard-Andersen; P Szymański; T Melvin; P Piscoi; Alan Fraser; Piotr Szymański; Chris P Gale; Aldo P. Maggioni; Elisabetta Zanon; Christina Dimopoulou; Cinzia Ceccarelli; Polyxeni Vairami; Anett Ruszanov; Per Kjærsgaard-Andersen; Rob Nelissen; Adrian Ott; Elizabeth Macintyre; Loredana Simulescu; Marieke Meijer; Berthold Koletzko; Sarah Wieczorek; Adamos Hadj
Opublikowane w:
European Heart Journal - Quality of Care and Clinical Outcomes, Numer Volume 8 , Numer 3, 2021, Strona(/y) 249–258, ISSN 2058-1742
Wydawca:
Oxford University Press on behalf of the European Society of Cardiology
DOI:
10.1093/ehjqcco/qcab059
Autorzy:
Lübbeke, A., Combescure, C., Barea, C., Gonzalez, A. I., Tucker, K., Kjærsgaard-Andersen, P., Melvin, T., Fraser, A. G., Nelissen, R., & Smith, J. A.
Opublikowane w:
EFORT Open Reviews, Numer Volume 8, Numer 11, 2023, Strona(/y) 781-791, ISSN 2058-5241
Wydawca:
British Editorial Society of Bone & Joint Surgery
DOI:
10.1530/eor-23-0024
Autorzy:
Guerlich, K., Patro-Golab, B., Barnacle, A., Baumann, U., Eicken, A., Fraser, A. G., Gruszfeld, D., Haas, N. A., Jonker, A. H., Kammermeier, M., Kenny, D., Kolaček, S., Lapatto, R., Maconochie, I., Mader, S., McGauran, G., Melvin, T., Muensterer, O., Piscoi, P., Romano, A.
Opublikowane w:
European Academy of Paediatrics, Numer Volume 112, Numer 11, 2023, Strona(/y) 2440-2448, ISSN 0803-5253
Wydawca:
Taylor & Francis
DOI:
10.1111/apa.16919
Autorzy:
Arjola Bano, Juri Künzler, Faina Wehrli, Lum Kastrati, Tania Rivero, Adea Llane, Angelica Valz Gris, Alan G. Fraser, Christoph Stettler, Roman Hovorka, Markus Laimer, Lia Bally, null null
Opublikowane w:
Diabetes, Obesity and Metabolism, 2024, ISSN 1462-8902
Wydawca:
Blackwell Publishing Inc.
DOI:
10.1111/dom.15849
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