During the past year, as scientists in different parts of the world began developing vaccines against the Covid 19 virus, we have gradually become familiar with the idea of clinical trials and their importance in our lives. Every time a new drug, a new vaccine, a new medical device or a new treatment procedure is developed, there is a trial run done to make sure that they are safe for use in humans and are sufficiently efficient to treat a specific health condition. The trial run and all the steps involved in it is a clinical trial.
Clinical trials are done in 3 phases. In Phase 1, the researchers administer the drug to participants to see whether the drug is safe to use and the highest dose that can be given to humans without any adverse side effects. During Phase 2, researchers administer the safest dose and try to figure out whether the new drug, vaccine or experimental treatment is effective in combating the specific disease that it is designed to treat. For example, a phase 2 trial drug for cancer may successfully lead to the shrinking of solid tumours in participating cancer patients. Phase 3 of the trial aims to find out how safe and efficient the new drug or treatment is compared to the current ones that are in use. The participants are divided into 2 groups, one group is administered the new, experimental treatment, the other group is given the treatment already in use or in case none is available, a sugar pill. Neither the doctors nor the patients in this phase of the study know which individual patient receives which type of treatment in this phase. If the new drug, vaccine treatment is found to be safe enough and more beneficial compared to the older ones, the authorities grant approval for its widespread use.
A trial run involves people who are selected on the basis of specific criteria like age, sex, population group, suffering from a disease at present or with a history of a specific illness. The details of the procedure, potential risks and benefits of the new treatment is explained to the participants and consent is taken before proceeding.
Clinical trials are not just needed for a newly prepared drug or treatment. If an already in use drug that was effective in treating a disease in adults is found to treat the same disease in children, new clinical trials need to be done in children before it is approved. Sometimes, there are new discoveries like a drug previously used for treating malaria contains properties that would be helpful for patients suffering from another disease caused by a virus. This old drug with a new purpose then undergoes a trial run to see how well it works against the viral disease.