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Publication Practices Among Pivotal Clinical Trials of High-Risk Medical Devices

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dc.contributor.author DONIN, Gleb
dc.contributor.author KOZIK, Martin
dc.date.accessioned 2023-11-10T11:16:34Z
dc.date.available 2023-11-10T11:16:34Z
dc.date.issued 2023
dc.identifier.citation DONIN, Gleb, KOZIK, Martin. Publication Practices Among Pivotal Clinical Trials of High-Risk Medical Devices. In: 6th International Conference on Nanotechnologies and Biomedical Engineering: proc. of ICNBME-2023, 20–23, 2023, Chisinau, vol. 2: Biomedical Engineering and New Technologies for Diagnosis, Treatment, and Rehabilitation, 2023, p. 3-10. ISBN 978-3-031-42781-7. e-ISBN 978-3-031-42782-4. en_US
dc.identifier.isbn 978-3-031-42781-7
dc.identifier.isbn 978-3-031-42782-4
dc.identifier.uri https://doi.org/10.1007/978-3-031-42782-4_1
dc.identifier.uri http://repository.utm.md/handle/5014/24758
dc.description Acces full text - https://doi.org/10.1007/978-3-031-42782-4_1 en_US
dc.description.abstract The main objective of the study was to analyze the clinical studies in SSED documents that are submitted to the FDA in the premarket approval process and compare it with the information in related peer-reviewed publications. A total of 59 medical devices that met the inclusion criteria were identified in the time period 2014–2018. Of the 64 pivotal clinical studies, 81% were published, with a median time to publication of 2 months. There were no substantial differences in randomization and blinding between SSED pivotal trials and publications. Small differences were noticed in the number of patients (8%), the mean patient age and sex (15%). No differences were observed between SSED documents and published studies in terms of primary outcomes selection and definition. Only three (3.8%) outcomes were not found in publications. Our results shown a substantial improvement both in the publication rate of the pivotal trials and in the correctness of the published information for high-risk cardiovascular medical devices. en_US
dc.language.iso en en_US
dc.publisher Springer Nature Switzerland en_US
dc.rights Attribution-NonCommercial-NoDerivs 3.0 United States *
dc.rights.uri http://creativecommons.org/licenses/by-nc-nd/3.0/us/ *
dc.subject medical devices en_US
dc.subject regulatory process en_US
dc.subject premarket approval en_US
dc.subject clinical studies en_US
dc.subject publication practice en_US
dc.title Publication Practices Among Pivotal Clinical Trials of High-Risk Medical Devices en_US
dc.type Article en_US


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  • 2023
    6th International Conference on Nanotechnologies and Biomedical Engineering, September 20–23, 2023, Chisinau, Moldova

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Attribution-NonCommercial-NoDerivs 3.0 United States Except where otherwise noted, this item's license is described as Attribution-NonCommercial-NoDerivs 3.0 United States

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