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Clinical Study Definitions

Adjuvant treatments are additional treatments given after the primary treatment to decrease the risk of a recurrence. For cancer, the primary treatment is typically surgery. This may then be followed by an adjuvant treatment: chemotherapy, radiation, hormonal therapy or biological therapy.

Clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Blinded clinical trial
A clinical trial in which neither researchers nor patients know which patients are receiving the standard therapy and which are receiving the experimental therapy until after the trial is completed.

Clinical trial
Research to test new drugs or treatments in human subjects. Clinical trials are carefully designed studies that closely monitor patients as they go through treatment with a new drug.

Before reaching the clinical trial stage, the drug or treatment typically will have been studied in a laboratory and also in pre-clinical trials on animals. Clinical trials are designed to answer questions about a drug's safety or effectiveness.

Informed consent
Before patients make the decision to participate in a clinical trial, they are given detailed information about the study, including what treatments will be tested, the possible side effects and the time commitment required.

Investigational means that the drug or procedure being tested is experimental. If it is a drug, it has received government approval to be used in clinical trials, but has not been approved for treatment outside of a trial for that type of cancer. It may, however, have been approved for the treatment of a different type of cancer.

Sometimes called a "sugar pill," a placebo is a pill or treatment that looks like the drug being tested but it does not contain the effective ingredient. Placebos are used in research to control what is called the "placebo effect": an effect that is attributable to the power of suggestion, or to the expectation that the drug will have an effect.

Pre-clinical trial
Before new drugs or treatments are tested on human beings in clinical trials, they are tested on animals in pre-clinical trials.

Raloxifene is used to prevent osteoporosis in postmenopausal women. It is also being studied as a cancer-prevention drug.

Randomized trial
A randomized clinical trial, also called a Phase III trial, typically compares the effectiveness of a new treatment to the standard treatment using a large, varied group of patients. Hundreds or even thousands of patients may be needed for one clinical trial, and patients should represent the population the treatment is designed to help. Patients are randomly assigned to the different arms of the trial, usually by computer, in order to ensure the validity of the results.

SWOG stands for the Southwest Oncology Group, one of the world's largest cancer clinical trial organizations. Its members include almost 4,000 doctors at 283 institutions in the United States and Canada.

SCCA researchers participate in a number of clinical trials through SWOG