Tuesday, April 26, 2016

Clinical Trial Phases

There are three phases of clinical trials in which a treatment is studied before the treatment is eligible for approval by the FDA (Food and Drug Administration).

The purpose of a Phase I study is to find the best way to administer a new treatment and to determine how much of it can be given safely. Physicians watch patients carefully for any harmful side effects. The research treatment has been well tested in laboratory and animal studies, but the side effects in human patients are not completely predictable in this phase.

Phase II trials determine the effectiveness of a research treatment after safety has been evaluated in a Phase I trial. Patients are closely observed for an anticancer effect by careful measurement of cancer sites present at the beginning of the trial. In addition to monitoring patients for response, any side effects are carefully recorded and assessed.

Phase III trials require the entry of large numbers of patients; some trials enroll thousands of patients. One of the groups may receive standard (the most accepted) treatment so the new treatments can be directly compared. The group that receives the standard treatment is called the “control group.” For example, one group of patients (the control group) may receive the standard chemotherapy for a certain type of cancer, like mesothelioma, while another patient group may receive another type of chemotherapy that may or may not contain an investigational drug to see if this improves survival. All patients in Phase III trials are monitored closely for side effects, and treatment is discontinued if the side effects are too severe.

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