Have you watched Hotstar web series Human and movie Umeed, both of which were released this year.
Both of these were based on drug trials. Now i will explain how a ethical drug trial is done.
Pre clinical studies
These studies are done in animals to check whether the drug is safe or not and whether it is effective or not. To check these, we make animal models.
Clinical Trials
Now we do testing of the drug in humans. This is called clinical trials. We divide Clinical trials in to various phases. Before starting the clinical trials, we have to go to a licensing authority : FDA in USA and DCGI in India.
Phase I
In this phase, small number of healthy people are enrolled. We cannot do efficacy testing because of healthy volunteers. We can test whether the drug is safe or not. The main aim of this phase is to find the maximum tolerable dose.
Phase II
This phase is done in patients. In this phase, nearly 500 patients are taken. In this phase, we can do efficacy testing of the drug. In this phase, patients are taken from a single centre. Maximum risk of failure is in this phase.
Phase III
In this phase, large number of patients, up to 5000 are enrolled. This phase is done in multiple centres. In this phase, efficacy is confirmed.
After this trial, we send the details of phase I, II and III trials to DCGI and ask the permission to market the newly developed drugs.
Phase IV
This trial is also known as post marketing study. Main aim of this trial is to identify rare side effects of the drug. These adverse effects are known only when drug is given to a large number of people. Long term side effects can also be known. In this phase, maximum number of patients are assessed.
Phase 0 Trial
This trial is known as micro dosing study. This is not mandatory for every drug. This helps us to know about the mechanism of the drug in the body.
Thank You.