About Clinical Studies

Clinical studies are an essential part of creating a new drug to help someone with a particular condition or disease. A new drug must go through comprehensive testing to ensure that it helps effectively treat a condition or disease for which it is targeting. It must also be safe enough for the person to take, and have as little side effects as possible. Clinical trials involving humans is one of the most important steps before a drug can be submitted to a regulatory agency for approval. There are several phases that a new drug must go through before it is considered for approval.

Pre-Clinical Phase?

� This stage of research is done before testing in humans, and is designed to test the major safety profile of the drug.
Phase 0-1 (I)

� These phases are designed to test the effects of the new medication on the body and how the body metabolizes the new medication. Testing is done in small groups of people (50-200), where tolerability of the new medication is monitored, as well as screening for safety.
Phase 2 (II)

� New medication is given to a larger testing group (100-400), with target disease. Phase 2 is designed to further test medications safety and efficacy.
Phase 3 (III)

� Larger groups are tested with (1000-5000), with target disease. The purpose of phase 3 is to confirm medications effectiveness, monitor any side effects, and collect more information on safety and dosage.
Phase 4 (IV)

� Once a new drug has been approved, post marketing studies are conducted. Phase 4 is to confirm a medications value, by comparing it to real world data and to similar medication already on the market.

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Emergency Case