CORDIS fournit des liens vers les livrables publics et les publications des projets HORIZON.
Les liens vers les livrables et les publications des projets du 7e PC, ainsi que les liens vers certains types de résultats spécifiques tels que les jeux de données et les logiciels, sont récupérés dynamiquement sur OpenAIRE .
Livrables
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 devicesThe 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 devicesCentral 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 AIExpert 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 designsA 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 networkingA 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• 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 bodiesA publication with the results of EU and other experience relating to clinical evidence generation after market access.
An Ethics Charter for Innovation in Medical DevicesFollowing 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 trialsExpert recommendations on methods for evaluating clinical trials and studies of highrisk medical devices
Dissemination & Communication PlanDefinition of COREMD dissemination and communication activities providing detailed information on brand recognition target groups media synergies
Report on dissemination and networkingA 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 surveillanceIncluding 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 devicesPublished 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 trainingA 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 devicesA 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 handbookThis 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 manuscriptsPublication of main analysis and principal secondary/sensitivity analyses.
Publication on early-phase clinical studies of high-risk medical devicesReport 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 resourcesEach 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.
Publications
Auteurs:
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.
Publié dans:
European Heart Journal, Numéro Volume 44, Numéro 36, 2023, Page(s) 3405-3422
Éditeur:
Oxford Academy
DOI:
10.1093/eurheartj/ehad514
Auteurs:
Siontis, G. C. M., Frenk, A., & Windecker, S.
Publié dans:
European Health Journal, Numéro Volume 45, Numéro 7, 2024, Page(s) 553-554
Éditeur:
Oxford University Press
DOI:
10.1093/eurheartj/ehad806
Auteurs:
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.
Publié dans:
International Journal of Health Policy and Management, Numéro Volume 12, Numéro 1, 2023, Page(s) 1-11
Éditeur:
Kerman University of Medical Sciences
DOI:
10.34172/ijhpm.2023.7648
Auteurs:
Fraser AG, Nelissen RGHH, Kjærsgaard-Andersen P, Szymański P, Melvin T, Piscoi P
Publié dans:
EFORT Open Reviews, Numéro Volume/Numéro: Volume 6: Numéro 10, 2021, Page(s) 839–849
Éditeur:
EFORT
DOI:
10.1302/2058-5241.6.210081
Auteurs:
Siontis, G. C., Frenk, A., Coles, B., Bartkowiak, J., McGovern, L., Häner, J., Tomii, D., Galea, R., Häberlin, A., Praz, F., & Windecker, S.
Publié dans:
2022
Éditeur:
PROSPERO
Auteurs:
Bano, A., Laimer, M., Wehrli, F., Kunzler, J., Rivero, T., Fraser, A. G., Stettler, C., Hovorka, R., & Bally, L.
Publié dans:
BMJ, Numéro Volume 13, Numéro 4, 2023
Éditeur:
BMJ
DOI:
10.1136/bmjopen-2022-070672
Auteurs:
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
Publié dans:
European Heart Journal, Numéro Volume 43, Numéro 3, 2021, Page(s) 161-177
Éditeur:
Oxford University Press
DOI:
10.1093/eurheartj/ehad567
Auteurs:
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
Publié dans:
European Heart Journal, Numéro Volume 44, Numéro Supplement_2, 2023
Éditeur:
Oxford University Press
DOI:
10.1093/eurheartj/ehad655.3001
Auteurs:
Guerlich, K., Patro-Golab, B., Dworakowski, P., Fraser, A. G., Kammermeier, M., Melvin, T., & Koletzko, B.
Publié dans:
Pediatric research, Numéro Volume 95, Numéro 3, 2024, Page(s) 615-624
Éditeur:
Springer Nature
DOI:
10.1038/s41390-023-02819-4
Auteurs:
Hoogervorst, L.
Publié dans:
2022
Éditeur:
OSF
Auteurs:
Siontis, G. C., Frenk, A., Coles, B., Bartkowiak, J., McGovern, L., Häner, J., Tomii, D., Galea, R., Häberlin, A., Praz, F., & Windecker, S.
Publié dans:
National Institute for Health and Care Research, 2022
Éditeur:
PROSPERO
Auteurs:
Wild C., Ettinger S.
Publié dans:
Journal of Medical Device Regulation, Numéro Volume 20, Numéro 2, 2023, Page(s) 45-56
Éditeur:
Global Regulatory Press
Auteurs:
Lübbeke, A.
Publié dans:
EFORT Open Reviews, Numéro Volume 8, Numéro 11, 2024, Page(s) 781-791
Éditeur:
Zenodo
DOI:
10.5281/zenodo.10623389
Auteurs:
Ren, Y., & Caiani, E. G.
Publié dans:
Zenodo, 2024
Éditeur:
Zenodo
DOI:
10.5281/zenodo.10864069
Auteurs:
Gibello R., Ren Y., Caiani E.G.
Publié dans:
European Heart Journal, Numéro Volume 44, Numéro Supplement_2, 2023
Éditeur:
Oxford University Press
DOI:
10.1093/eurheartj/ehad655.3024
Auteurs:
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.
Publié dans:
Expert review of medical devices, Numéro Volume 20, Numéro 6, 2023, Page(s) 467-491
Éditeur:
Taylor & Francis
DOI:
10.1080/17434440.2023.2184685
Auteurs:
Szymański, P., & Redberg, R.
Publié dans:
European Heart Journal, Numéro Volume 45, Numéro 3, 2024, Page(s) 178-180
Éditeur:
Oxford University Press
DOI:
10.1093/eurheartj/ehad786
Auteurs:
Schnell-Inderst, P., Kuehne, F., Holborow, R., Rochau, U., & Siebert, U.
Publié dans:
Value in Health, Numéro Volume 25, Numéro 12, 2022
Éditeur:
Elsevier Inc
DOI:
10.1016/j.jval.2022.09.1878
Auteurs:
Hoogervorst, L.
Publié dans:
OSG Registries, 2023
Éditeur:
OSF
DOI:
10.17605/osf.io/r87vt
Auteurs:
Guerlich, K., Bernadeta, P., Michael, K., Paulina, D., & Berthold, K.
Publié dans:
OSF REGISTRIES, 2023
Éditeur:
OSF
DOI:
10.17605/osf.io/uzekt
Auteurs:
Smith, J. A., Combescure C., Barea C., Lübbeke-Wolff A.
Publié dans:
2021
Éditeur:
OSF
DOI:
10.17605/osf.io/9bjqv
Auteurs:
Bano, A.
Publié dans:
Zenodo, 2025
Éditeur:
Zenodo
DOI:
10.5281/zenodo.10894441
Auteurs:
Siontis, G.
Publié dans:
Zenodo, 2024
Éditeur:
Zenodo
DOI:
10.5281/zenodo.10617117
Auteurs:
Chaplin, J., Rolfson, O., Jarke, H., Moons, P., Norekvål, T., & Holm Ingelsrud, L.
Publié dans:
National Institute for Health and Care Research, 2022
Éditeur:
PROSPERO
Auteurs:
Melvin T., Kenny D., Gewillig M., Fraser A.G.
Publié dans:
Pediatric Cardiology, Numéro Volume 44, Numéro 2, 2023, Page(s) 271-279
Éditeur:
Springer Nature
DOI:
10.1007/s00246-022-03029-1
Auteurs:
Ren, Y., Bertoldi, M., Fraser, A. G., & Caiani, E. G.
Publié dans:
Therapeutic Innovation & Regulatory Science, Numéro Volume 57, Numéro 3, 2023, Page(s) 589-602
Éditeur:
Springer Nature
DOI:
10.1007/s43441-022-00493-y
Auteurs:
López, J. A., Dobrzynska, A., Lozano, M. P. R., Parrilla, J. C. R., Epstein, D. M., & Amaro, J. A. B.
Publié dans:
National Institute for Health and Care Research, 2023
Éditeur:
PROSPERO
Auteurs:
Schnell-Inderst, P., Kühne, F., Rochau, U., Schmid, D., & Siebert, U.
Publié dans:
2022
Éditeur:
OSF
Auteurs:
Gibello, R.
Publié dans:
2023
Éditeur:
POLIMNI
Auteurs:
Ivan Gibanica I.
Publié dans:
2023
Éditeur:
GOETEBORGS UNIVERSITET
Auteurs:
Chaplin J.
Publié dans:
Quality of Life Research, Numéro Volume 32, Supplement_2, 2023, Page(s) 23-220
Éditeur:
Springer Nature
DOI:
10.1007/s11136-023-03530-x
Auteurs:
Ren Y., Bertoldi M., Caiani E.G.
Publié dans:
European Heart Journal, Numéro Volume 43, Numéro Supplement_2, 2022
Éditeur:
Oxford University Press
DOI:
10.1093/eurheartj/ehac544.2842
Auteurs:
Ren Y. and Caiani E.G.
Publié dans:
2023 IEEE EMBS International Conference on Biomedical and Health Informatics (BHI), 2023, Page(s) 1-4
Éditeur:
IEEE
DOI:
10.1109/bhi58575.2023.10313402
Auteurs:
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
Publié dans:
European Heart Journal - Quality of Care and Clinical Outcomes, Numéro Vol. 8 , no. 3 , pp. 249–258, 2021, ISSN 2058-1742
Éditeur:
Oxford University Press on behalf of the European Society of Cardiology
DOI:
10.1093/ehjqcco/qcab059
Auteurs:
Lübbeke, A., Combescure, C., Barea, C., Gonzalez, A. I., Tucker, K., Kjærsgaard-Andersen, P., Melvin, T., Fraser, A. G., Nelissen, R., & Smith, J. A.
Publié dans:
EFORT Open Reviews, Numéro Volume 8, Numéro 11, 2023, Page(s) 781-791, ISSN 2058-5241
Éditeur:
British Editorial Society of Bone & Joint Surgery
DOI:
10.1530/eor-23-0024
Auteurs:
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.
Publié dans:
European Academy of Paediatrics, Numéro Volume 112, Numéro 11, 2023, Page(s) 2440-2448, ISSN 0803-5253
Éditeur:
Taylor & Francis
DOI:
10.1111/apa.16919
Auteurs:
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
Publié dans:
Diabetes, Obesity and Metabolism, 2024, ISSN 1462-8902
Éditeur:
Blackwell Publishing Inc.
DOI:
10.1111/dom.15849
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