What is a clinical trial?

A clinical trial is a research study that evaluates a new treatment to help doctors determine its safety and effectiveness. Clinical trials rely on the participation of patients who volunteer to try new or modified treatments.

All therapies that Huntsman Cancer Institute investigates through clinical trials have been thoroughly researched in the laboratory. Laboratory results have given researchers reason to believe that these treatments may prove more effective than current cancer therapies or that they will provide additional treatment options for cancer patients. The next step is to study these possible new treatments in a clinical, rather than laboratory, setting.

Why would a patient be interested in clinical trials?

Usually patients participate in clinical trials because they hope to benefit themselves and because they want to contribute to a research effort that helps other cancer patients.

Researchers conducting clinical trials of a new cancer therapy believe that it may be more effective than the current standard treatment, so patients in a clinical trial may receive the benefit of the new treatment before it would otherwise be available. Whether the outcome is beneficial or disappointing, patients involved in clinical trials are helping to find new and better treatments for cancer.

Not all clinical trial participants will receive the new treatment. The participants who do not are called the control group; they provide the comparison between the existing treatments and the new treatments.

How do patients know whether they qualify for a clinical trial at Huntsman Cancer Institute?

Together, the patient, the patient's physician, and those who administer Huntsman Cancer Institute's clinical trials decide whether a patient is eligible to participate in a specific study. Each clinical trial looks for patients with a specific type and stage of cancer who are in a relatively good state of health. Some prior cancer treatments may disqualify you for a clinical trial, and your age may also be an important factor. All patients treated in a particular clinical trial must be in similar physical condition to accurately compare the results of experimental therapies. In general, you must

• Have your cancer diagnosed and then "staged" (evaluated for how far it has spread)
• Have your general health status reviewed by a physician
• Have all of your treatment-related and clinical trial questions answered to your satisfaction
• Give your informed consent, which means that you understand the possible risks and benefits of participating in a clinical trial

What are the risks of participating in a clinical trial?

Clinical trials of new treatments may cause side effects. Some side effects are known and expected, but others may not be known ahead of time. Though researchers make every effort to discover and explain to patients what side effects may occur from clinical trial treatments, serious side effects are a possible outcome from participation in clinical trials.

A patient's well-being is paramount in a clinical trial. If you are involved in a clinical trial, you will be closely monitored to see how you are responding to treatment and to determine your overall well-being. If the experimental treatment becomes clearly detrimental to you, it will be discontinued. In addition, you may withdraw from the study at any time if you change your mind about participating in it.

What kinds of clinical trials are there?

Phase I clinical trials are first-time tests of drugs or treatments in humans. Though the drug or treatment has not yet been tested on people, researchers have reason to believe that it will be beneficial. At this stage, researchers do not know the drug's effectiveness, the best dose to administer, or what side effects may occur. A suggested starting dose for humans is found through laboratory experimentation. All patients involved in Phase I clinical trials receive a form of treatment for their cancer; none are administered placebos (medically inactive drugs sometimes used in medical research for comparison purposes).

Phase II clinical trials begin after Phase I trials have defined an appropriate dosage of the drug. In this stage of testing, researchers will determine the drug's effectiveness in treating a specific kind and stage of cancer. As in Phase I clinical trials, all patients involved in Phase II clinical trials receive active treatment; none are administered placebos.

Phase III clinical trials test agents that have proven to be effective in the first two stages of testing. Phase III clinical trials put the new (investigational) therapy in perspective. For example, a phase III trial may compare the current standard therapy against the new investigational therapy. Or it may compare patients given both the investigational therapy and standard therapy with those who are administered only the standard therapy. Patients participating in Phase III trials are randomly assigned to one of the treatments in the study. This means a patient is selected by chance to be in one treatment group or another. This randomization is essential to allow investigators to determine which therapy is truly more effective. While Phase I and Phase II trials may involve a few dozen patients, Phase III trials can include hundreds of patients.

What does it cost to be in a clinical trial?

The study sponsor may pay some of the costs associated with the clinical trial. However, because nearly all clinical trials include administering some standard treatment to the patient, some costs are billed to the insurance company and/or the patient (any "standard" treatment charges can be billed to the insurance provider). Before you enroll in a clinical trial, you should understand which costs will be paid by the study sponsor, which costs will be charged to your insurance company, and which costs may be billed to you.

For More Information about Clinical Trials

Clinical Trials Office
(801) 581-4477
clinical.trials@hci.utah.edu

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