Journal
IEEE JOURNAL OF BIOMEDICAL AND HEALTH INFORMATICS
Volume 25, Issue 10, Pages 3977-3982Publisher
IEEE-INST ELECTRICAL ELECTRONICS ENGINEERS INC
DOI: 10.1109/JBHI.2021.3090469
Keywords
Animals; Computational modeling; Safety; In vitro; Drugs; Predictive models; Biological system modeling; Context of use; good simulation practice; In silico trials
Categories
Funding
- STriTuVaD Project [H2020-SC1-2017-CNECT-2/777123]
- CompBioMed2 Project [H2020-INFRAEDI-2018-1/823712]
- InSilicoWorld Project [H2020-SC1-DTH-20201/101016503]
Ask authors/readers for more resources
In Silico Trials involve the use of computer modeling and simulation to evaluate the safety and efficacy of medical products. These predictive models are considered new methodologies for product development and regulatory evaluation. Defining a Context of Use is crucial for the regulatory assessment process, and it is important to identify potential applications and establish a taxonomy of categories for these innovative methodologies.
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
I am an author on this paper
Click your name to claim this paper and add it to your profile.
Reviews
Recommended
No Data Available