For the betterment of our society and for scientific and medical research to move forward, it is vital to conduct clinical research in the form of clinical trials. This is the gateway to understand new ways to prevent, detect and treat diseases. Ranging from new diagnostic techniques to new surgical procedures and new drugs are all part of clinical research. Unlike in the past, when mishaps such as the Thalidomide disaster and Tuskegee syphilis study occurred violating personal rights, today clinical trials are conducted in a very professional way and is tightly regulated by the US-FDA and needs to abide by the ICH-GCP principles, to safeguard the rights safety and well being of the trial subjects.
How do new drugs come into the market?
The purpose of conducting clinical research is to explore medical strategies which are safe and effective for humans and thus advance medical knowledge. The development of a new vaccine or drug does not happen overnight and takes many years, after a tight and rigorous process with many filtration to ultimately hit the market. Also not all drugs clinically tested, enter the market, they need to prove that they are safe and effective for human use and thus go through a series of phases, such as Phase I, II, III and post marketing surveillance.
In contradictory to the general social norms, that clinical trials use subjects as guinea pigs, clinical trials are highly coordinated and the subjects are only taken to be part of a clinical trial, after signing an informed consent form and only then any clinical trial related procedure can start on a subject. The informed consent form, contains all details of the clinical trial design, any adverse events reported and all details of the trial. Further, the subject is given ample time to decide and ask any questions prior to joining a clinical trial. Also he/she can withdraw from the clinical trial at any given point of time.
Thus by conducting clinical trials, clinicians test potential treatments in human volunteers to see whether the drugs should be approved for wider use in the general population. It becomes vital to conduct clinical trials, therefore to understand if the new treatment works well in humans and if it is safe to be used. Scientists are working constantly to upgrade the current therapies to more effective and safer ones with fewer side effects. As it happens in a tightly regulated setting, with pre-clinical trials done prior to human testing, it undertakes to keep the safety of the subjects.
