Clinical trials are conducted in phases. The trials at each phase have a different purpose and help scientists answer different questions. Potential treatments are studied in laboratory animals first to determine potential toxicity before they are tried in humans. Treatments having acceptable safety profiles and showing the most promise may then be considered for use in human clinical trials. It is not known whether a potential treatment offers benefits to patients until the clinical research is complete. Clinical trials are an integral part of new product discovery and development and are generally required by the U.S. Food and Drug Administration (FDA) before a new product can be brought to the market.
"Bringing a new pharmaceutical to market usually takes 12-15 years and can cost up to one billion dollars."
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Neuropsychiatric Research Center