Possible Contexts of Use for In Silico trials methodologies: a consensus- based review Article Swipe
Marco Viceconti
,
Luca Emili
,
Payman Afshari
,
Eulalie Courcelles
,
Cristina Curreli
,
Nele Famaey
,
Liesbet Geris
,
Marc Horner
,
Maria Cristina Jori
,
Alexander Kulesza
,
Axel Loewe
,
Michael Neidlin
,
Markus Réitérer
,
Cécile F. Rousseau
,
Giulia Russo
,
Simon J. Sonntag
,
Emmanuelle Voisin
,
Francesco Pappalardo
·
YOU?
·
· 2021
· Open Access
·
· DOI: https://doi.org/10.5445/ir/1000137059
YOU?
·
· 2021
· Open Access
·
· DOI: https://doi.org/10.5445/ir/1000137059
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.
Related Topics
Concepts
Computer science
Context (archaeology)
In silico
Process (computing)
New product development
Data science
Management science
Product (mathematics)
Regulatory science
Risk analysis (engineering)
Medicine
Engineering
Paleontology
Marketing
Mathematics
Biochemistry
Operating system
Pathology
Business
Biology
Chemistry
Gene
Geometry
Metadata
- Type
- review
- Language
- en
- Landing Page
- https://publikationen.bibliothek.kit.edu/1000137059
- OA Status
- green
- Cited By
- 44
- References
- 31
- Related Works
- 10
- OpenAlex ID
- https://openalex.org/W3176291648
All OpenAlex metadata
Raw OpenAlex JSON
- OpenAlex ID
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https://openalex.org/W3176291648Canonical identifier for this work in OpenAlex
- DOI
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https://doi.org/10.5445/ir/1000137059Digital Object Identifier
- Title
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Possible Contexts of Use for In Silico trials methodologies: a consensus- based reviewWork title
- Type
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reviewOpenAlex work type
- Language
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enPrimary language
- Publication year
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2021Year of publication
- Publication date
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2021-01-01Full publication date if available
- Authors
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Marco Viceconti, Luca Emili, Payman Afshari, Eulalie Courcelles, Cristina Curreli, Nele Famaey, Liesbet Geris, Marc Horner, Maria Cristina Jori, Alexander Kulesza, Axel Loewe, Michael Neidlin, Markus Réitérer, Cécile F. Rousseau, Giulia Russo, Simon J. Sonntag, Emmanuelle Voisin, Francesco PappalardoList of authors in order
- Landing page
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https://publikationen.bibliothek.kit.edu/1000137059Publisher landing page
- Open access
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YesWhether a free full text is available
- OA status
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greenOpen access status per OpenAlex
- OA URL
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https://doi.org/10.5445/ir/1000137059Direct OA link when available
- Concepts
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Computer science, Context (archaeology), In silico, Process (computing), New product development, Data science, Management science, Product (mathematics), Regulatory science, Risk analysis (engineering), Medicine, Engineering, Paleontology, Marketing, Mathematics, Biochemistry, Operating system, Pathology, Business, Biology, Chemistry, Gene, GeometryTop concepts (fields/topics) attached by OpenAlex
- Cited by
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44Total citation count in OpenAlex
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2025: 9, 2024: 18, 2023: 9, 2022: 8Per-year citation counts (last 5 years)
- References (count)
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31Number of works referenced by this work
- Related works (count)
-
10Other works algorithmically related by OpenAlex
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| citation_normalized_percentile.value | 0.98555566 |
| citation_normalized_percentile.is_in_top_1_percent | False |
| citation_normalized_percentile.is_in_top_10_percent | True |