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

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

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 organized 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.

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 Reiterer, Cecile F. Rousseau, Giulia Russo, Simon J. Sonntag,
Emmanuelle M. Voisin, and Francesco Pappalardo.


Published on: Jun 28, 2021
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    publication by

    Cécile Rousseau
    Cécile F. Rousseau, PhD
    Senior Director, Nonclinical
    With 10+ years in nonclinical and translational research and histotechnology, Dr. Cécile F. Rousseau has considerable expertise in medical devices,…
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    Emmanuelle M. Voisin, PhD
    Emmanuelle M. Voisin, PhD
    Founder and CEO
    Dr. Emmanuelle Voisin founded Voisin Consulting Life Sciences (VCLS) in 1997. The firm has become a leading advisor to Biotech,…
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