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Clinical trials are conducted in phases. The trials at each phase
have a different purpose and help scientists and clinicians
answer different questions.
In Phase I trials, researchers test a new drug or treatment in a
small group of people, usually 20- 80 participants, for the first
time to evaluate its safety, determine safe dosage, and identify
side effects. This phase trial attempts to determine how the study
treatment affects the human body.
In Phase II trials, the drug or treatment under study is given to a
larger group of people, usually 100-300 participants, to determine if
it is effective and to further evaluate its safety and to see how the
study agent affects a particular type of cancer.
In Phase III trials, the drug or treatment under study is given to
thousands of people, usually 1,000 - 3,000 participants, with the disease
to confirm its effectiveness, monitor side effects, compare it to commonly
used standard treatment, and collect information that will allow the drug
or treatment to be used safely.
In Phase IV post-marketing studies trials look for additional information
including the drug's or treatment's risks, benefits and optimal use.
For more information, call the McGivney Center at (203) 789-3545 at the Hospital of Saint Raphael or e-mail Pat Garofolo, M.S., B.S.N., study coordinator.
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