Phase I trials test new treatments for safety in humans and
any harmful side effects. These studies usually include a limited
number of patients who would not be helped by other known treatments
Phase II trials determine whether the new treatment is
effective against specific tumors. A small number of people
participate because risks and benefits are largely unknown.
Phase III trials compare the result of people taking the new
treatment with results of people taking standard treatment. Phase III
testing occurs only when a protocol shows promise in Phases I and
II. Phase III trials may include hundreds of people around the
country.
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