History has shown us that humans have won the battles with various pandemics in the past. Some of them battles took very little time and some contrarily took a few years. However, whatsoever was the duration, it were only humans who were successful in eradicating a pandemic. Generally, a vaccine helps to control the pandemic spread by a virus. But, creating a vaccine is time taking process. Once the virologist discovers a virus and decodes its genome, the next step starts with developing a vaccine for it. Vaccines undergo clinical trial in different phases before it is available for the patients.
The clinical trial is a method of testing and observing the effects of different measures like vaccine, therapy, and treatment on the subject . To put it simply, it is a process where the medical scientists check new methods that may work on the particular disease.
What are the phases of a clinical trial?
Clinical trial is a process having four phases. They are namely
In this phase, the medical scientist select a very small group of volunteers or the patients (generally between 6 to 10 in number). Then, they give a dose of medicine the group. In this phase doctors and medical scientists observe the effect of the medical compound in the human subjects. The main objective of this study is to know how safe and tolerable this compound is for the human body once it is inside their body. After this, subjects get under observation for any side effects they may experience.
This phase is performed once the safety of the medicine confirms in phase one. In phase two, the size of the group is bigger than phase one. Generally, 20 to 300 subjects are selected. The numbers of the subjects may vary depending on the type of disease.
Phase two checks the safety and the intended result of the medicine in subjects. Different doses of the medicine are given to the subjects to check its effects. This helps the doctors to selects the most effective and safest dose for the patients.
There are many instances where multiple phase study is conducted to test the medicine on different people.
In this phase, the study includes a large number of people ranging from 300 to 3000 or more. The medical scientist tests the safety and viability of medicine in this phase. Here, the large groups helps to provide a confirm proof of safety and efficacy of the medicine. Moreover, the study helps in comparing medicine with other possible treatments and draws the best solution. The information obtained from this phase renders the best use of medicine in the future.
It is the post-marketing surveillance trial phase. It is conducted once the medicine has received the marketing authorization and it has been designed to provide the viability and safety information among the people. In addition, phase 4 helps to evaluate the long term effect of the medicine. In this phase, it is less possible to observe any adverse events.