What Are the Different Phases of a Clinical Trial?
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Phase I clinical trial. A new research treatment is given to a small number of participants and emphasizes safety. The researchers determine the best way to give the new treatment, find out the drug’s most frequent and serious side effects, and how much of it can be given safely.
Phase II clinical trials. Determine the effect of a research treatment on the particular disease or condition being evaluated.
Phase III clinical trials. Compare the new treatment with the standard treatment and study different populations and different dosages and combinations of drugs.
Phase IV clinical trials. Apply the new treatment to general patient care (after FDA approval for marketing); for example, a new drug that was found effective in a clinical trial may be used together with other effective drugs to treat the particular disease or condition in a select group of patients.