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Participating in Clinical
Trials
Frequently Asked Questions
13. What are the phases of a clinical
trial? - cont'd
A
Phase II trial is similar to a Phase I trial but uses more people
to find out if the experimental treatment is effective and safe.
This phase can last several years.
A
Phase III trial is a large study using several hundred or more
participants. This phase compares the experimental drug or
procedure to a placebo or standard treatment, to make sure it is
safe and works well. Some side effects that didn't show up in Phase
II may show up in a Phase III trial because many more people are
tested.
If
the U.S. Food and Drug Administration agrees that the trial results
are positive, they will approve the experimental drug or
device.
(Answer continues on next page.)
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