In silico clinical trials: concepts and early adoptions

In silico clinical trials: concepts and early adoptions

Professor Marco Viceconti, Executive Director of the Insigneo Institute for in silico Medicine, has contributed to an article published in Briefings in Bioinformatics which reviews the current state of in silico clinical trials and outlines directions for a full-scale adoption of patient-specific modelling and simulation in the regulatory evaluation of biomedical products.

In recent years, new approaches in modelling and simulation have started to provide important insights in biomedicine, opening the way for their potential use in the reduction, refinement and partial substitution of both animal and human experimentation. In light of this evidence, the European Parliament and the United States Congress made similar recommendations to their respective regulators to allow wider use of modelling and simulation within the regulatory process.

In the context of in silico medicine, the term ‘in silico clinical trials’ refers to the development of patient-specific models to form virtual cohorts for testing the safety and/or efficacy of new drugs and of new medical devices. Moreover, it could be envisaged that a virtual set of patients could complement a clinical trial (bringing the benefits of reducing the number of enrolled patients and improving statistical significance), and/or advise clinical decisions.

The article provides an introduction to in silico medicine and in silico Clinical Trials (ISCT) and covers:

  • Potential adoption of computational modelling and algorithms in ISCT
  • Examples of early adoption
  • Future opportunities for ISCT
  • The future: towards an in silico-driven drug development

In particular, it focuses on the development of vaccine therapies, including cancer immunoprevention, which represent an ideal target for this innovative approach.

In silico clinical trials: concepts and early adoptions (Briefings in Bioinformatics) F. Pappalardo, G. Russo, F. Musuamba Tshinanu, M. Viceconti