Clinical trials are essential to the development of new drugs and medicines, and they offer new insights every day about important advances in medical research. But in order to test a drug or device and find out if it’s safe and effective, you need clinical research participants willing to participate.
At least, that’s how it used to be.
According to a new proof-of-concept study published in Nature Communications, clinical studies conducted with simulated participants rather than real, flesh-and-blood participants may yield findings that are just as effective and clinically valid as the traditional trial approach, raising new questions about the future of clinical research.
Specifically, researchers at the University of Leeds attempted to replicate 3 previous studies of a device used to treat brain aneurysms by creating virtual participants. Instead of recruiting real people, the research team used a clinical database of patient characteristics and attributes to build a simulated patient population for the study. Details about each digital participant included basic physical traits and features, to more complex simulated experiences, such as how a body might interact with a specific drug or device.
After running their simulation, researchers found that the predictions it made about the number of patients who would respond favorably to treatment matched findings produced in the 3 person-based studies, suggesting a replicable result.
Studies with virtual participants, called in-silico studies, are not a new concept, though they have received renewed interest since the COVID-19 pandemic, which disrupted a lot of clinical research activity. In silico trials, while by no means a replacement for traditional clinical research methodologies, do offer a potentially safer and more efficient way to collect important safety and efficacy data about a drug.
"The results demonstrate the huge potential of in-silico trials. We have shown that the approach can replicate the findings of traditional clinical trials -- and they do that in a fraction of the time it normally takes, and at a fraction of the cost,” said Professor Alex Frangi, one of the studies supervisors.
Source: Science Daily