In silico clinical trials: how computer simulation will transform the biomedical industry


  • Marco Viceconti Department of Mechanical Engineering and INSIGNEO Institute for In silico Medicine, University of Sheffield
  • Adriano Henney VPH Institute for Integrative Biomedical Research
  • Edwin Morley-Fletcher Linkeus srl



Computer modelling and simulation, Clinical trials, In silico medicine, Predictive medicine


The term ‘in silico clinical trials indicates the use of individualised computer simulation in the development or regulatory evaluation of a medicinal product, medical device, or medical intervention. This review article summarises the research and technological roadmap developed by the Avicenna Support Action during an 18 month consensus process that involved 577 international experts from academia, the biomedical industry, the simulation industry, the regulatory world, etc. The roadmap documents early examples of in silico clinical trials, identifies relevant use cases for in silico clinical trial technologies over the entire development and assessment cycle for both pharmaceuticals and medical devices, identifies open challenges and barriers to a wider adoption and puts forward 36 recommendations for all relevant stakeholders to consider.


Viceconti M, Henney A, Morley-Fletcher E, eds. In silico Clinical Trials: how computer simulation will transform the biomedical industry. Brussels: Avicenna Consortium 2016. DOI: 10.13140/RG.2.1.2756.6164

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