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What is In Silico Medicine?

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The term In Silico Medicine has various definitions, each stressing one particular dimension. 

The in silico definition that we as consortium endorse, and that we consider relevant for the context of this project, is this:

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"The use of Computer Modelling & Simulation to support the medical decision on prevention, diagnosis, prognosis, or treatment."

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In simpler words, the computer model can predict things that are difficult or impossible to measure directly, but that are very useful in guiding the decision of the medical professional.   

While not all in silico medicine technologies are patient-specific, we strongly endorse models that can make such prediction for each individual patient of a cohort, models which accuracy is tested by comparing the prediction for each patient with the value measured in that patient. 

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Some important roots of in silico medicine are in a European initiative called the Virtual Physiological Human (VPH), that was first described in a white paper in 2005. In 2015, to celebrate the tenth anniversary, Prof Marco Viceconti and Prof Peter Hunter, two of the leading figures in this emerging field, wrote a review paper entitled “The Virtual Physiological Human: Ten Years After” that provides a detailed historical review of the early developments of this field.  

One of the first VPH research projects funded by the European Commission was entitled "ImmunoGrid - The European virtual human immune system project". This research project, which run from 2006 to 2009, developed the foundations of the Universal Immune System Simulator(UISS), which is the core technology used in the STriTuVaD project. 

 

What are In Silico Trials?

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According to the Avicenna Roadmap, the term In Silico Clinical Trials indicates

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“The use of individualised computer simulation in the development or regulatory evaluation of a medicinal product or medical device/medical intervention”.  

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Because these technologies are being used to replace both pre-clinical and clinical experimental studies with their computational counterparts, in the last few years the term most commonly used became In Silico Trials, which includes both. 

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In 2013 the European Commission funded a support action, named after the Arabian physician and philosopher Avicenna, which drove the strategic development of this new application of in silico technologies. In 2016 the Avicenna consortium published a research roadmap entitled “In silico Clinical Trials: How Computer Simulation will Transform the Biomedical Industry” written through the contribution of over 600 experts worldwide with clinical, technological, industrial, and regulatory background; this document is very important for and had a profound impact on the emergence of this field.

One of such impacts was the epochal decision made between late 2015 and early 2016 by the USA Congress and the European Parliament, to make to their respective regulatory agencies (FDA - Food and Drug Administration, and EMA - European Medicines Agency) a very similar recommendation around in silico trials. 

Until then it was virtually impossible to produce any evidence of safety or efficacy in the regulatory process that had not been produced experimentally, either in vitro (e.g. cell cultures), in vivo on animals, or through clinical trials. Since 2016 both regulatory agencies started to develop regulatory frameworks within which also in silico trials evidences could be presented, once properly qualified. 

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