who fit into the study are very technical, so a doctor who is familiar with the patient's case should make the contact with the doctors listed in PDQ as being directly responsible for the protocol .
The Phases of Clinical Trials Clinical trials show doctors which therapies are more effective. For example, some compare the best-known surgical treatment with a newer operation to see if one produces more cures and causes fewer side effects than the other. Many standard treatments were first shown to be effective in clinical trials. The state-of-the-art therapies recommended in PDQ should be considered a foundation for building new and better treatments. Treatment protocols are designed to take advantage of what has worked in the past and to improve on this foundation.
Clinical trials are carried out in distinct steps, or phases. Each phase is designed to discover certain types of information. Each phase depends on, and builds on, information from an earlier phase. Patients may be eligible for studies in different phases, depending on their general condition and the type and stage of their cancer.
• Phase I The purpose of a Phase I study is to find the best way to give a new treatment and how much of it
can be given safely. The new treatment is given to a small number of patients, and doctors watch carefully for
any harmful side effects. The treatment has already been well tested in laboratory and animal studies, but the
side effects in humans are not completely predictable. For this reason, Phase I studies may involve significant
risks and are offered only to patients whose cancer has spread and who would not be helped by known
