Clinical Trial Phases
 
 

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.