A clinical trial which is a particular computer simulation and used in the development or regulatory evaluation of a medicinal product, device, or intervention is called as an In-Silico Clinical Trial.
The behavior of the drug or device reaction, when deployed in the general population or when used in particular circumstances can be predicted with the help of latest computer modelling. This process is helpful to protect the public from the unintended consequences of side effects and drug interactions.
The process before a new drug is released into the market is long and tedious. It consists of pre-clinical (animal) and clinical (human) trials that test the safety and efficacy of the drug before its distribution. However, most drugs are abandoned if they fail in these “all or nothing”, expensive evaluations, even if only a slight modification is required.
What if there was a method that told us why the drug failed and suggested improvements?
We’ve heard of in vivo (inside living organisms) and in vitro (test tubes in laboratories) trials. What if there was a third test that rules out ineffective control scenarios in a cost-effective manner before human use?
This is known as an in silico clinical trial. It develops patient-specific models to perform a virtual cohort study to test new drugs, via realistic computer simulations using closed-loop control algorithms that guide and focus the trials.
The main components of the computer simulation environment include a mathematical model closely representing human metabolism; a sufficiently large cohort of in silico subjects, created by collecting data from previous clinical trial volunteers; an in silico sensor that finds errors in time-lag, calibration, and system; and pumps/devices for drug delivery.
Simulink, a part of the larger software MATLAB, is used to create the testing scenario, select the subjects to form the cohort, select the sensor and pump, and decide the outcome metrics.
In 2006, The Juvenile Diabetes Research Foundation, initiated the Artificial Pancreas Project to carry out closed-loop glucose control research using in silico trials. In silico trials produce reliable results that can substitute various preclinical trials in a fraction of the time it would usually take. However, good in silico performance doesn’t guarantee good in vivo performance and hence cannot substitute clinical trials, but serves as a prerequisite.