New Jersey Commission on Cancer Research

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What is a Clinical Trial?

prepared by the
New Jersey Commission on Cancer Research
Excerpts from: What are Clinical Trials All About, National Institutes of Health, National Cancer Institute

Advances in science and medicine are the results of new ideas and hard work developed through research. In cancer research, a clinical trial is an investigational study conducted with cancer patients, usually to test a new treatment. This search for new and better ways to treat cancer usually begins with basic research in a laboratory and animal studies. After careful testing, treatments with promise are then studied in patients. Each study is designed to answer specific scientific questions so that new and better ways can be found to help cancer patients. There are many kinds of clinical trials, ranging from studies examining ways to prevent, detect, control and treat cancer, to studies looking at ways to improve a patients quality of life. Patients in a clinical trial receive their care in the same places that standard treatments are given - at cancer centers, hospitals, clinics, or doctor's offices.

To be eligible for a clinical trial, your specific cancer type, stage and treatment status must meet the criteria of an active study. If you are eligible, you may be asked to participate in a trial. Your can also inquire whether such trials are available for your cancer. Patients are very carefully monitored to assure that they are receiving the utmost benefits of the new program. As with any new treatment, there are risks as well as benefits. For this reason, it is important to find out all that you can about an investigational study before you decide to participate.

Why consider taking part in a clinical trial?
Cancer patients may want to consider taking part in a clinical trial for many reasons. Usually they hope for benefits for themselves. They hope for a cure of disease, a longer time to live, or a way to feel better. Often they want to contribute to a research effort that may help others. Most importantly, the decision to enter a clinical trial or not is always up to you.

Are there risks or side effects in clinical trials?
Yes. The treatments used in clinical trials can cause side effects and other health risks depending on the type of treatment and the patient's condition. Because clinical trials are research into new areas of treatment, the risks involved are not always known ahead of time, though serious efforts have been made to find out what they might be. You should make sure you understand all of the known risks before you decide to participate in a study.

What is Informed Consent?
Patients need to know what is involved in a study. Your doctor or nurse will tell you about the treatment being tested and will give you a form to read that explains the risks and hoped-for benefits. Before your agree to participate and sign this informed consent form be sure you understand the purpose of the study and what risks you face. Ask the doctor or nurse to explain any parts of the form or the trial that are not clear.

Weighing the Risks and Potential Benefits.
As a cancer patient, it can be hard to decide about your treatment. There are a number of things to consider. Cancer is a life-threatening disease which causes symptoms of its own that are not related to treatment. The unavoidable risks of the cancer itself and your condition should be weighed against the potential risks and benefits of a new research treatment.

For More Information Call:
The NJ Commission on Cancer Research (609) 633-6552 or the Cancer Information Service of the National Cancer Institute 1-800-4-CANCER (1-800-422-6237)