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Clinical Trial

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The U.S. government requires that strict testing be applied to all new drugs or treatments prior to their approval for use as therapeutics agents. A clinical trial is a scientific study of how a new medicine or treatment works in people with the ultimate aim of obtaining Food and Drug Administration (FDA) approval. It involves testing a new medication or treatment that is not yet approved by the FDA or tests an already approved drug for a new use. With the exacting oversight of the FDA, it is a carefully conducted investigation of the effects of a drug or treatment given to humans with a goal of defining its pharmacologic effects and/or clinical usefulness.