How virtual clinical trials look set to revolutionise the world of medicine

One of the main factors that made our stunning Covid-19 vaccine roll-out possible was the speed, facilitated by the ­collaboration of scientists of many ­nations around the world working in unison on clinical trials.

These trials prove the safety and ­efficacy of the vaccines so licences can be approved, and they were a triumph of medical cooperation.

Could we do it again? Well, yes, and we could even do it virtually.

So instead of recruiting people to a real-life clinical trial, researchers build digital simulations of patients in the way virtual populations are built in The Sims computer game.

These ‘in-silico’ simulations could revolutionise the way clinical trials are done, reducing the time and cost of getting new medicines and medical devices developed, while reducing human and animal harm in testing.

Virtual patients are developed from clinical data to reflect age, sex and ethnicity but they also imitate the way disease affects the human body.

Those simulations are then used to model the impact of therapies and interventions. The international research, led by the University of Leeds, investigated whether an in-silico trial could reproduce the results of three real-life clinical trials that assessed the effectiveness of a device called a flow diverter.

These are used in the treatment of brain aneurysms, where the wall of a blood vessel weakens and begins to bulge. Without successful treatment, the aneurysm can burst, causing a bleed on the brain and a stroke.

The researchers built a virtual population using patient data drawn from clinical databases, ensuring that the anonymised virtual patients closely resembled the patients used in real clinical trials in terms of age, sex and aneurysm characteristics.

The in-silico trial had 82 virtual cases. Three traditional clinical trials had 109, 141 and 207 patients respectively. Around half the cases in the traditional trials had high blood pressure. The results of the in-silico trial predicted that 82.9% of the virtual patients with normal blood pressure would be successfully treated. In the traditional clinical trials, the number of people who were successfully treated was 86.8%, 74.8% and 76.8% respectively, showing that the in-silico trial ­replicated the traditional clinical trial results quite closely.

Professor Alex Frangi of the Royal Academy of Engineering at the University of Leeds, who supervised the study, said: “The results demonstrate the huge potential of in-silico trials.

“We have shown it can replicate the findings of traditional clinical trials – and they do that in a fraction of the time it normally takes [five to eight years], and at a fraction of the cost.

“In-silico trials could reduce this period to less than six months in some circumstances, making knowledge and therapeutic technologies safer and more promptly available to clinicians and patients.”