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What are Clinical Trials? Back to Home

 

Clinical Trials are controlled patient studies that must be performed before a new drug or treatment is approved by the FDA. They are also done after a drug or treatment is approved to document the effectiveness of the treatment or to gain FDA approval to use the drug or therapy to treat a different disease. There are three main phases to clinical trials, done in sequence. A Phase I study tests the safety and side effects of the drug. A Phase II study is initiated to determine the efficacy of the drug, to see if it works as anticipated. A Phase III study tests the results on a large population of volunteers.

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