Possible Contexts of Use for in Silico Trials Methodologies: A Consensus-Based Review
| Autor: | Cécile F. Rousseau, Axel Loewe, Marc Horner, Nele Famaey, Michael Neidlin, Francesco Pappalardo, Marco Viceconti, Luca Emili, Emmanuelle M. Voisin, Payman Afshari, Markus Reiterer, Eulalie Courcelles, Simon J. Sonntag, Cristina Curreli, Maria Cristina Jori, Giulia Russo, Liesbet Geris, Alexander Kulesza |
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| Přispěvatelé: | Viceconti M., Emili L., Afshari P., Courcelles E., Curreli C., Famaey N., Geris L., Horner M., Jori M.C., Kulesza A., Loewe A., Neidlin M., Reiterer M., Rousseau C.F., Russo G., Sonntag S.J., Voisin E.M., Pappalardo F. |
| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
Technology
Computer science 02 engineering and technology Quantitative Biology - Quantitative Methods 030218 nuclear medicine & medical imaging Predictive models 0302 clinical medicine Community of practice Health Information Management 0202 electrical engineering electronic engineering information engineering Regulatory science Quantitative Methods (q-bio.QM) Context of use Class (computer programming) Computer Science Information Systems Management science Biological system modeling Drugs Computational modeling 3. Good health Computer Science Applications Biological Physics (physics.bio-ph) Computer Science Interdisciplinary Applications 020201 artificial intelligence & image processing ddc:620 Safety Life Sciences & Biomedicine Biotechnology In silico trials Consensus Process (engineering) FOS: Physical sciences Context (language use) 03 medical and health sciences In vitro In silico medicine Taxonomy (general) good simulation practice Animals Humans Computer Simulation Physics - Biological Physics Product (category theory) Electrical and Electronic Engineering Engineering & allied operations Science & Technology EFFICACY FOS: Biological sciences Computer Science Mathematical & Computational Biology Medical Informatics |
| Zdroj: | IEEE Journal of Biomedical and Health Informatics, 25 (10), 3977-3982 |
| ISSN: | 2168-2194 2168-2208 |
| Popis: | 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. Comment: Submitted to IEEE JOURNAL OF BIOMEDICAL AND HEALTH INFORMATICS |
| Databáze: | OpenAIRE |
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