National Cancer Institute National Cancer Institute
U.S. National Institutes of Health National Cancer Institute
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Taking Part in Cancer Treatment Research Studies
    Posted: 07/17/2007
Clinical Trials Take Place in Phases

For a treatment to become part of standard treatment, it must first go through 3 or 4 clinical trial phases. You do not have to take part in all phases. The early phases make sure the treatment is safe. Later phases show if it works better than the standard treatment.

Purpose Number of people who take part
Phase I
To find a safe dose
To decide how the new treatment should be given
To see how the new treatment affects the human body
15-30 people
Phase II
To determine if the new treatment has an effect on a certain cancer
To see how the new treatment affects the human body
Less than 100 people
Phase III
To compare the new treatment (or new use of a treatment) with the current standard treatment From 100 to thousands of people
Phase IV
To further assess the long-term safety and effectiveness of a new treatment Several hundred to several thousand people