What is Clinical Research?
Organized research on human being intended to provide adequate information on the drug use as a therapeutic agent on its safety and efficacy.
What is Clinical Trial ?
Clinical trials, also known as Clinical Studies, are research studies in which scientists and doctors test new drug and treatments to see if they will improve health. Many of today’s treatments for cancer are based on the result of past clinical trials. Because of program made through clinical trials, many people treated for cancer are now living longer.
Clinical trials are divided into four phases
Phase I trials :
These trials are the first time a new drug or treatment is given to human. They are normally carried out in a small number of volunteers (Typically 6-20 People) who may include healthy volunteers or patients.
Phase II Trials :
These trials involve larger number of people (typically 12-50). Phase 2 trials continue to look at safety of the therapy but also test how well the new drug or treatment works in patients with different disease types.
Phase III Trials :
These are large studied(100+people) that look at how well a new drug or treatment works in comparison to current therapies to see which treatment is better
Phase IV Trials :
These trials are usually carries out after the drug or treatment has been approved by the FDA and is readily available for use in the general patient population. The purpose of Phase 4 trials is to continue to study the effects of the drug or treatment on different population and to look for side effects associated with long-term use.