Cracking the Code: Unveiling the Trustworthy World of In-Silico Trials

Are computational models ready to replace traditional clinical trials? This episode delves into the fascinating world of in silico trials and their growing role in regulatory evaluation of biomedical products. We explore a methodological framework based on the ASME VV-40-2018 standard that establishes credibility through verification, validation, and uncertainty quantification. From defining contextual use to conducting thorough risk analysis, we examine how these principles apply across statistical, machine learning, Bayesian, and agent-based models. We compare regulatory approaches between different authorities and make the case for wider adoption of credibility assessment standards to ensure reliable virtual evidence. Join us as we navigate the cutting edge of computational modelling in healthcare regulation.

 

Viceconti M, Pappalardo F, Rodriguez B, Horner M, Bischoff J, Musuamba Tshinanu F. In silico trials: Verification, validation and uncertainty quantification of predictive models used in the regulatory evaluation of biomedical products. Methods. 2021 Jan;185:120-127.