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Clinical Study Phases

Each phase of a medical research study has a different focus, but they all work toward the main goal of finding a new or improved treatment. Clinical study phases range from phase 1 to phase 4, each with different objectives. For example, phase 1 studies determine how much of the treatment should be given and how it should be given, while phase 4 studies deal with things such as long-term effects of treatment.

What Are Different Phases of Clinical Studies?

Medical research studies (also known as clinical trials) are usually divided into a few different phases. Each phase has a different focus, but they all work toward the main goal of finding a new or improved treatment. These different phases include:
  • Phase 1
  • Phase 2
  • Phase 3
  • Phase 4.
Phase 1 Clinical Studies
In Phase 1, a new drug or treatment is tested on a small group of people -- usually about 20 to 80. The new treatment has already been tested for safety in the lab and in animals, and has shown to have good potential for helping people. It has also been submitted to a government regulatory agency and approved for use in human testing.
The purpose of this phase is to find out if the treatment is safe for humans, and if so, how much should be given and how. Those who participate in this phase are watched very closely, and the researchers record and study any side effects that happen after taking the study drug.
Phase 2 Research Studies
In Phase 2, a larger group of people receives the drug or treatment. There can also be a placebo group that does not receive the new treatment. The main purpose of this phase is to find out whether or not the new treatment is actually effective in treating the patient's disease or medical condition. The safety of the drug or treatment continues to be studied in this phase, and any side effects are carefully reviewed.
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