Before a new treatment can be used on people, it is studied in the lab. If lab studies suggest the treatment will work, the next step is to test its value for patients. These studies in humans are called clinical trials. Clinical trials are needed to find new and better ways to treat people with cancer. You cannot be placed in a clinical trial without first volunteering for it, being informed about it, and signing a special consent form for it. Clinical trials are carried out in steps called phases. Each phase is designed to answer certain questions.

The main questions the researchers want to answer are:

• Is this treatment helpful?
• How does it work?
• Does it work better than the one we’re now using?
• What side effects does it cause?
• Do the benefits outweigh the risks, including the side effects?
• Which patients are most likely to find this treatment helpful?

During cancer treatment, your doctor may suggest taking part in a clinical trial. This does not mean that you are being asked to serve as a human "guinea pig." Nor does it mean that your case is hopeless and that your doctor is suggesting a last-ditch effort. A clinical trial is done only when there is some reason to believe that the treatment being studied may be more helpful than what is now in use.

Ask your doctor if there is a clinical trial that might be right for you. Then learn all you can about it. There may be risks as well as benefits. If you change your mind, you can leave the clinical trial at any time.

What the patient can do

• Ask about the purpose of the clinical trial.
• Ask about what the clinical trial involves, including what kinds of tests and treatments it might include.
• Ask about what other treatments might work for you if you do not take part in the clinical trial.
• Ask about how the study can affect your daily life.
• Ask about side effects that might result from the treatment and what can be done about these side effects.
• Ask how long the study will last.
• Ask about the need to be in the hospital, and find out how long and how often you may need to be in the hospital.
• Ask about the costs. Will any of the treatment be free? Will your insurance cover the costs?
• Ask about what treatment will be offered if you should be harmed as a result of the clinical trial.
• Ask about the type of long-term follow-up care that is offered as part of the clinical trial.
• Ask what will happen and how to go about it if you decide to drop out of the clinical trial.

What caregivers can do

• Encourage the patient to ask the doctor about clinical trials.
• Go with the patient to learn about any clinical trial he is considering.
• Be sure the patient’s questions have been answered to his satisfaction before enrolling in a clinical trial.

For more in-depth information on clinical trials, call your American Cancer Society at 1-800-227-2345. You may want to ask for a copy of Clinical Trials: What You Need to Know. You can also find more information on the Web at cancer.org.

Go back to Caring for the Patient with Cancer at Home: A Guide for Patients and Families.

Last Medical Review: 04/27/2009
Last Revised: 04/27/2009