Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
- Phase I: Researchers test a new drug or treatment
in a small group of people for the first time to evaluate its safety,
determine a safe dosage range, and identify side effects.
- Phase II: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
- Phase III: The drug or treatment is given to large
groups of people 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.
- Phase IV: Studies are done after the drug or
treatment has been marketed to gather information on the drug's effect
in various populations and any side effects associated with long-term
use.
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