| Clinical Trial Phases | |
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At Idaho Urologic Institute, you may be asked to participate in a Phase 2-4 trial. Phase 2 Phase 2 studies are performed to measure the safety and effectiveness of an investigational product. Patients will be randomized, like flipping a coin, to receive either the investigational product or a placebo. Typically, the investigator and patient are blinded during this process, referred to as a double blind. Randomization and blinding occur to remove any bias that may occur during this process. Phase 3 Phase 3 studies are conducted to determine the safety and effectiveness of an investigational product, as in Phase 2. However, it is a pivotal point in determining statistically that the drug really works. Again, patients may receive the investigational product or a placebo. Investigators and patients are typically blinded during this phase. Phase 4 If a drug is approved by the FDA for marketing, Phase 4 studies will begin. Phase 4 studies are conducted to continue monitoring safety and effectiveness of a market approved drug. The manufacturer may also decide to test this drug for other indications at this time. |
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