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Clinical Trials
An Introduction to Clinical Trials
Clinical trials are conducted in phases. The trials at each phase have a different purpose and help scientists answer different questions:
The four testing steps are as follows:
| PHASE I | PHASE II | PHASE III | PHASE IV |
|---|---|---|---|
| In Phase I 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. | In Phase II 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. | In Phase III trials, 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. | In Phase IV trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use. |
Updated: 6-8-2003
Clinical Trial Studies