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Possible Contexts of Use for In Silico trials methodologies: a consensus- based review

Viceconti, M.; Emili, L.; Afshari, P.; Courcelles, E.; Curreli, C.; Famaey, N.; Geris, L.; Horner, M.; Jori, M. C.; Kulesza, A.; Loewe, A. ORCID iD icon 1; Neidlin, M.; Reiterer, M.; Rousseau, C. F.; Russo, G.; Sonntag, S. J.; Voisin, E. M.; Pappalardo, F.
1 Institut für Biomedizinische Technik (IBT), Karlsruher Institut für Technologie (KIT)


The term In Silico Trial indicates the use of computer modelling and simulation to evaluate the safety and efficacy of a medical product, whether a drug, a medical device, a diagnostic product or an advanced therapy medicinal product. Predictive models are positioned as new methodologies for the development and the regulatory evaluation of medical products. New methodologies are qualified by regulators such as FDA and EMA through formal processes, where a first step is the definition of the Context of Use (CoU), which is a concise description of how the new methodology is intended to be used in the development and regulatory assessment process. As In Silico Trials are a disruptively innovative class of new methodologies, it is important to have a list of possible CoUs highlighting potential applications for the development of the relative regulatory science. This review paper presents the result of a consensus process that took place in the InSilicoWorld Community of Practice, an online forum for experts in in silico medicine. The experts involved identified 46 descriptions of possible CoUs which were organised into a candidate taxonomy of nine CoU categories. ... mehr

Verlagsausgabe §
DOI: 10.5445/IR/1000137059
Veröffentlicht am 12.09.2021
DOI: 10.1109/JBHI.2021.3090469
Zitationen: 22
Web of Science
Zitationen: 17
Zitationen: 26
Cover der Publikation
Zugehörige Institution(en) am KIT Institut für Biomedizinische Technik (IBT)
Publikationstyp Zeitschriftenaufsatz
Publikationsmonat/-jahr 10.2021
Sprache Englisch
Identifikator ISSN: 2168-2194, 2168-2208
KITopen-ID: 1000137059
Erschienen in IEEE Journal of Biomedical and Health Informatics
Verlag Institute of Electrical and Electronics Engineers (IEEE)
Band 25
Heft 10
Seiten 3977-3982
Vorab online veröffentlicht am 23.06.2021
Nachgewiesen in Dimensions
Web of Science
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