The highly commended paper reports the first in silico clinical trial for a medical device, exemplifying the potential of computer-based testing and trials to replace the use of animals and accurately predict the safety and efficacy of medical devices.
In silico trials can provide evidence to ensure only treatments with the highest likelihood of clinical benefit and lowest risk of complications progress to later-stage testing, avoiding the use of animals in preclinical safety and efficacy studies. In their paper, Alex and Ali presented the flow diverter (FD) performance assessment (FD-PASS) in silico trial, which reproduced and expanded on findings from clinical trials of endovascular devices to treat brain aneurysms.
Research into treating vascular diseases of the brain (e.g. aneurysm and stroke) typically uses large animals including pigs, dogs and rabbits. Between 2000 and 2015, more than 430 rabbits and 160 dogs were used in studies focusing on the flow-diverting stents that Alex and Ali modelled in silico. By modelling the treatment of intracranial aneurysms in virtual patients, they were able to replicate the findings from in vivo experiments that took years and over 600 animals to produce, in a matter of days.
In addition, Alex and Ali’s in silico model goes beyond what is possible in conventional animal and human trials. They were able to identify new risk factors for treatment failure and assess an individual patient’s risk of ischemic and haemorrhagic complications, supporting clinical decisions to be made on a case-by-case basis. The model’s virtual patient approach has broad potential applications across disciplines, for example in cardiovascular (heart valves and pacemakers) and musculoskeletal (hip and knee replacements) medicine. The paper adds to the body of reliable regulatory evidence that is critical to support the adoption of in silico testing and trials in the UK and internationally. It was a key driver in establishing the in silico medicine innovation network (InSilicoUK), a community of scientists, learned societies and SMEs brought together by Innovate UK to advance the use of in silico approaches which replace the use of animals and improve patient outcomes.
Sarrami-Foroushani A et al. (2021). In-silico trial of intracranial flow diverters replicates and expands insights from conventional clinical trials. Nat Commun 12:3861. doi:10.1038/s41467-021-23998-w