Understanding Clinical Trials

What are clinical trial phases?

Clinical trials of experimental drugs proceed through four phases:

Phase I
Clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase II
Clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
Phase III
Studies, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase IV
Studies are done after the drug or treatment has been approved for marketing. These studies continue testing the study drug or treatment to collect information about its effect in various populations and any side effects associated with long-term use.

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