Possible Contexts of Use for In Silico trials methodologies: a consensus- based review
Repository KITopen (Karlsruhe Institute of Technology)
Abstract
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.
Authors 18
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Istituto Ortopedico Rizzoli · University of Bologna
Affiliation as printed
Department of Industrial Engineering, Alma Mater Studiorum–University of Bologna, Bologna, Italy
Medical Technology Laboratory, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy
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Affiliation as printed
In Silico Trials Technologies, Milano, Italy
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Johnson & Johnson (United States)
Affiliation as printed
DePuy Synthes Spine, Johnson and Johnson, Raynham, MA 02767, USA
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Affiliation as printed
Novadiscovery SAS, Lyon, France
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Istituto Ortopedico Rizzoli · University of Bologna
Affiliation as printed
Department of Industrial Engineering, Alma Mater Studiorum–University of Bologna, Bologna, Italy
Medical Technology Laboratory, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy
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Affiliation as printed
Biomechanics Section, Department of Mechanical Engineering, KU Leuven, Leuven, Belgium
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University of Liège · KU Leuven
Affiliation as printed
Biomechanics Research Unit, University of Liège, Liège, Belgium
Biomechanics Section, Department of Mechanical Engineering, KU Leuven, Leuven, Belgium
Division of Skeletal Biology and Engineering Research Center, KU Leuven, Leuven, Belgium
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Affiliation as printed
ANSYS, Inc, Evanston, IL 60201, USA
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Affiliation as printed
Mediolanum Cardio Research, Milano, Italy
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Affiliation as printed
Novadiscovery SAS, Lyon, France
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Karlsruhe Institute of Technology
Affiliation as printed
Institute of Biomedical Engineering, Karlsruhe Institute of Technology (DE), Karlsruhe, Germany
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Michael Neidlin Aachen Department of Cardiovascular Engineering Institute of Applied Medical Engineering
Affiliation as printed
Department of Cardiovascular Engineering, Institute of Applied Medical Engineering, RWTH Aachen University (DE), Aachen, Germany
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Affiliation as printed
Medtronic, PLC, Minneapolis, MN, USA
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Affiliation as printed
Voisin Consulting Life Sciences, Boulogne, 92100 Paris, France
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Affiliation as printed
Department of Drug and Health Sciences, University of Catania (IT), I-95125 Catania, Italy
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Affiliation as printed
Virtonomy GmbH, 81671 München, Germany
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Affiliation as printed
Voisin Consulting Life Sciences, Boulogne, 92100 Paris, France
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Affiliation as printed
Department of Drug and Health Sciences, University of Catania (IT), I-95125 Catania, Italy
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