What are clinical trials?

Phase I

The first phase seeks to try a new treatment on a small group. This group is typically comprised of 20-80 healthy participants. The purpose of this phase is to examine safety, side effects, and correct drug dosage.

Phase II

This phase typically has 100-300 participants. Phase II focuses on efficacy (effectiveness) of a new drug or treatment. Preliminary data is obtained from individuals with a particular disease or condition. Safety and short-term side effects are monitored. This phase often lasts several years.

Phase III

More information is gathered about safety and effectiveness in an even larger group (typically a few hundred up to 3,000). Different populations and dosages are studied using the new drug in combination with other drugs. If the FDA finds the trial results to be positive, the experimental drug, device, or treatment is approved.

Phase IV

Phase IV occurs after the FDA approves a drug, device, or treatment for use. The efficacy, safety, and side effects are monitored in large, diverse populations over a longer period of time.

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