Clinical Trial Phases Flashcards
What is Phase 1 of a clinical trial?
First time the drug is tested on humans where a small group of participants with and without the disease receive the treatment. This is to determine the safety of the drug, dosage and how it works in the human body.
What is Phase 2 of a clinical trial?
Larger group of participants who must have the disease in question to observe side effects and the effectivity of the drug.
What is phase 3 of a clinical trial?
Large group of participants with the disease receive the treatment to further monitor its effectiveness and compare with standard/alternative treatment and further monitor side effects.
What is Phase 4 of a clinical trial?
Drug is available to the public, and researchers continue to measure its safety, benefits and optimal use.
What is Phase 0 of a clinical trial?