A new treatment is always first studied in the laboratory. A new drug will be considered if it is found that it changes cells, or parts of cells, in a way that suggests that it will destroy cancer or help the body handle the side effects of cancer treatment. Based on what researchers learn from laboratory studies, and sometimes earlier clinical studies and standard treatments as well, they design a trial to see if a new treatment will improve on current treatments. Types of Trials Clinical trials are carried out in phases, each designed to find out certain information. Patients may be eligible for studies in different phases depending on their general condition and the type and stage of their cancer.
More patients take part in the later phases of studies than in the earlier ones.
In a Phase I study, a new research treatment is given to a small number of patients. The researchers must find the best way to give a new treatment and how much of it can be given safely. They watch carefully for any harmful side effects. The research treatment has been well tested in laboratory and animal studies but no one knows how patients will react. I studies may involve significant risks for this reason.