High-quality cancer clinical trials are an important component of quality cancer care. Before a new treatment method is made available to the public, it must undergo a clinical trial. Clinical trials, also called cancer treatment or research studies, test new treatments in people with cancer. Clinical trials test many types of treatment such as new drugs, new approaches to surgery or radiation therapy, new combinations of treatments, or new methods such as gene therapy.

Clinical trials are strictly monitored and carefully evaluated to test the therapy’s safety and efficacy (effectiveness). Any new treatment must successfully complete three phases of trials (see www.cancer.gov/clinicaltrials for a complete guide and description of Phase I, II and III trials) before the federal Food and Drug Administration (FDA) approves it for general use.

It’s important to know that every patient in a Phase III trial receives either the standard treatment for a specific cancer or the treatment being investigated. The common misperception that some patients receive placebos has kept many patients from participating in cancer clinical trials.

Is it right for me?

• Of course, there is no guarantee that a new treatment being tested or a standard treatment will produce good results. New treatments also may have unknown risks. In the past, clinical trials were sometimes seen as a last resort for people who had no other treatment choices. Today, patients with common cancers often choose to receive their first treatment in a clinical trial.

How do I decide?

• A number of excellent publications and Websites address this question. Reference the Patients section of the Coalition of National Cancer Cooperative Groups at www.cancertrialshelp.org. Before making a final decision, review the National Cancer Institute booklet If You Have Cancer: What You Should Know About Clinical Trials or check the information and questions at www.cancer.gov/clinicaltrials and click on Participating in a Trial: Questions to Ask Your Doctor.These important questions must be asked and answered to your satisfaction before you can make this decision. If you agree to participate, you will receive a copy of the written description of the trial. You will also be provided with an informed consent document that you must sign, indicating that you understand the trial and what will be required to participate.