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Different Phases of Research Studies

Clip Number: 3 of 13
Presentation: Clinical Trials
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Reviewed By: Arthur Schoenstadt, MD
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Research studies 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.
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.
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.
A large group of people are involved in Phase 3 studies. Those who participate in Phase 3 are usually randomly assigned to different groups. In one group, up to a few thousand people will receive the new treatment.
Another group receives the standard treatment for the same medical condition, or receives a placebo. This is called the "control" group. The side effects and treatment success in people receiving the new treatment are compared to those in the control group. This helps the researches know if the new treatment is really safer and more effective.
During this phase, researchers will continue to collect information about side effects, and also study how often the condition returns and the effects of the treatment on the patient's quality and length of life.
After Phase 3 studies are completed, a medicine can be submitted to the government for final approval.
Once a new treatment has been approved, there may be additional clinical studies performed. These are called Phase 4 studies. These studies are conducted for a number of reasons. One of these is to find out how effective the treatment is in different groups of people -- such as those of the same race or age group. Information is also gathered about long-term effects of the treatment.
 

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