Work

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

Year: 2016

Type: article

Abstract: 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.

Source: International Journal of Clinical Trials

DOI: 10.18203/2349-3259.ijct20161408

Authors: Marco Viceconti, Adriano Henney, Edwin Morley-Fletcher

Institutions: Insigneo, University of Sheffield, Valley Presbyterian Hospital

Language: English

Topic: Statistical Methods in Clinical Trials

Subfield: Statistics and Probability

Field: Mathematics

Domain: Physical Sciences

SDGs: Good health and well-being, Industry, innovation and infrastructure

Open Access status: diamond

Funder: European Commission