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Clinical Trial: Phases Explained

Clinical trials provide safe and effective testing of new methods and inventions of treatment, medication, and diagnosis for the use of the public. These methods and medications undergo clinical trials and are approved and licensed by the FDA for safe use. A drug may usually undergo a clinical trial to know whether it is safe to consume. Medical devices and new combinations of medication also undergo clinical trials. 

Various clinical trial centers, including clinical trials in Flemington, perform clinical trials and research studies for different cancer treatments where people can apply and receive therapies based on requirements. 

Pre-clinical research is sometimes followed before the actual clinical trial. This is performed using human cell cultures. If successful, then the actual clinical trial is performed on the human population. 

Overall, there are 5 phases of clinical trials, including an initial phase 0 and a phase 4 at the end. The various phases of clinical trials are described below:

Phase 0 –  This phase involves only a small number of people i.e. around 10-20 people tested for a minimal dose of medication. It is done to determine if the drug is safe for humans. If there are any side effects, the drug is not approved for the next phase. You probably have to give a few scans and blood samples to the researcher.

Phase 1 –  This phase involves around 20-50 healthy people. This phase is helpful to determine the distribution of the drug in the human body. This phase also seriously monitors any harmful or fatal adverse effects of the given drug. It also tells us about the ideal amount of drug required for safe treatment and how it can be administered. Approximately 70% of drugs, according to the FDA, are approved for phase 2.

Phase 2 involves around 100 volunteers who are patients of the disease for which the drug is being tested. These volunteers are tested in groups and monitored for several months or years. Phase 2 helps us to know how well and effective the treatment is against the disease. 

Phase 3 – this phase involves hundreds and thousands of volunteers. The new drug treatment is compared against the existing treatment available, also known as the standard treatment. Phase 3 aims to know which treatment is better and how the new treatment affects the quality of life.  

Phase 4 -This is the last phase of clinical trials, which happens only after the FDA has approved the treatment. It involves thousands of volunteers. Phase 4 continues for many years. This phase helps us to know about its prolonged use and benefit to the public.

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