Can computer simulation be used in clinical trials? The Avicenna project created a research and technological development roadmap describing how in silico techniques of computer simulation can be introduced into clinical trials.

This is a guest blog post by Marco Viceconti, Executive Director INSIGNEO institute for in silico medicine, University of Sheffield, UK

While computer simulation is widely used for developing and de-risking of a number of ‘mission-critical’ products such as civil aircraft, nuclear power plants, etc., the development and assessment of biomedical products is still predominantly founded on experimental rather than computer-simulated approaches.

Long and complex in vitro experiments, on animals, and then on patients during clinical trials, push development costs to unsustainable levels. It stifles innovation and drives the cost of healthcare provision to unprecedented levels.

To overcome this challenge, the Avicenna Action, funded by the European Union, has engaged 525 experts from 35 countries, including 22 of the 28 EU countries. In an 18-month consensus process, this action has produced a research and technological development roadmap for transforming the biomedical industry by describing the route by which in silico techniques of computer simulation can be introduced into clinical trials.

This document provides an overview of how biomedical products are being developed today. Readers can find out where in silico clinical trials technologies are already being used, and how this area could extend in the future. From the identification of the barriers that prevent wider adoption, we derived a detailed list of research and technological challenges that require pre-competitive funding to be overcome.

I suggest that the European Commission, and all other international and national research funding agencies support in silico clinical trial approaches, which could have huge socio-economic impact in the future.

I also propose that industrial and academic stakeholders explore the formation of a pre-competitive alliance to coordinate and implement public and privately funded research on this topic.

Last, but not least, I recommend that regulatory bodies across the world embrace innovation and, in collaboration with academic and industrial experts, develop the framework of standards, protocols and shared resources required to evaluate the safety and the efficacy of biomedical products using in silico clinical trials technologies (ISCT).

As the Avicenna consensus process demonstrated, in a globalised economy, the discourse on ISCT must be developed worldwide. Thus, all agencies should remove as many barriers as possible, and actively support pre-competitive research and technological development across countries and world regions.

The time is now, the challenge is huge. Only if we all work together will we be able to address and overcome that challenge.