  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.
