Article (Scientific journals)
Possible Contexts of Use for In Silico Trials Methodologies: A Consensus-Based Review.
Viceconti, Marco; Emili, Luca; Afshari, Payman et al.
2021In IEEE Journal of Biomedical and Health Informatics, 25 (10), p. 3977-3982
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Keywords :
Computer Simulation; Consensus; Humans
Abstract :
[en] 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. Examples of 31 CoUs were identified in the available literature; the remaining 15 should, for now, be considered speculative.
Disciplines :
Engineering, computing & technology: Multidisciplinary, general & others
Author, co-author :
Viceconti, Marco
Emili, Luca
Afshari, Payman
Courcelles, Eulalie
Curreli, Cristina
Famaey, Nele
Geris, Liesbet  ;  Université de Liège - ULiège > GIGA > GIGA In silico medecine - Biomechanics Research Unit
Horner, Marc
Jori, Maria Cristina
Kulesza, Alexander
Loewe, Axel
Neidlin, Michael
Reiterer, Markus
Rousseau, Cecile F
Russo, Giulia
Sonntag, Simon J
Voisin, Emmanuelle M
Pappalardo, Francesco
More authors (8 more) Less
Language :
English
Title :
Possible Contexts of Use for In Silico Trials Methodologies: A Consensus-Based Review.
Publication date :
October 2021
Journal title :
IEEE Journal of Biomedical and Health Informatics
ISSN :
2168-2194
eISSN :
2168-2208
Publisher :
Institute of Electrical and Electronics Engineers, Us
Volume :
25
Issue :
10
Pages :
3977-3982
Peer reviewed :
Peer Reviewed verified by ORBi
Available on ORBi :
since 29 June 2022

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