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Transcript: "What Is a Clinical Trial?"

Announcer: What is a clinical trial?

Clinical trials evaluate promising new cancer treatments or methods, from radiation and chemotherapy to new surgical techniques. This process helps determine if the new treatment is an improvement over existing treatments. For patients' safety, new treatments are developed in phases.

Initially, researchers look to find the best way to give the new therapy and see whether the treatment has any harmful effects. A second phase determines the effects of research treatment on various types of cancer. Once researchers are satisfied that the treatment has potential benefit and acceptable risk, they open clinical trials to large numbers of patients for the final test phase.

The new therapy is compared directly to existing standard therapy, to discover if the new therapy does, indeed, offer advantages. Patients may have a longer, more active life, or experience fewer and milder side effects from their treatment. If trial results warrant, the new treatment becomes standard therapy for all patients.

Dr. Stanley Watkins provides some examples.

Dr. Stanley Watkins: When I first started in practice, there were diseases such as breast cancer, testicular cancer, and Hodgkin's Disease where our cure rates were very low. As a result of clinical trials that have been going on for the past 20 years, we are now seeing very definite cure rates in these diseases, and the duration of the patient's life, the quality of their life, has changed dramatically. As a result, drugs, therapies, combinations of drugs, surgery, and radio therapy -- they have been put together through the use of clinical trials.

Announcer: Doctors carefully screen patients to find out if the clinical trial might be right for them. The medical treatment in clinical trials is given in a very specific manner, according to written instructions and guidelines called a protocol.

The protocol is like a recipe, to ensure a patient in California receives the same treatment as a patient in New York.

But since the protocol is written for physicians, your doctor will need to explain the treatment plan so you can decide whether to participate. When trials compare different treatments, each patient can receive only one of those treatments. Neither they nor their doctor chooses which treatment group they'll be in. This process, called "randomization," ensures different therapies are evaluated fairly. The outcome of a clinical trial cannot be guaranteed, and since the therapies and treatments are new, there's always some risk.

When discussing potential benefits, ask you doctor about potential risks of the trial you're considering. Of course, no patient with active cancer ever receives treatment known to be inferior. In fact, all clinical trial patients receive the highest quality medical care, with thorough, careful monitoring during the trial. Even with a very clear explanation, patients have many questions about their specific clinical trial. Potential side effects often tops the list.

From start to finish, each patient's best interest remains paramount. Whenever a patient's cancer fails to respond to therapy, the protocol treatment is stopped, so other treatment options can be pursued for that patient. In addition, every patient has the right to withdraw voluntarily from a trial at any time.

Another consideration -- how much will the experimental treatment cost and is it covered by insurance? Since every trial is different and insurance policies vary, be certain to discuss cost and reimbursement with both your doctor and insurance company. To enter a clinical trial, you must sign an informed consent statement.

This statement means you understand what treatments you may receive, possible side effects, your responsibility and possible outcomes. So before signing this statement, be sure to learn all you can about the study. To help you make a decision, the National Cancer Institute offers publications explaining your disease as well as clinical trials.

To receive such information, simply dial 1-800-4-CANCER.

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