© 2005-2012 American Society of Clinical Oncology (ASCO). All rights reserved worldwide.
Doctors and scientists are always looking for better ways to treat teenagers with cancer. To make scientific advances, doctors design research studies involving people, called clinical trials. Most teens with cancer are treated as part of a clinical trial. Many clinical trials test new treatments, evaluating whether a new treatment is safe, effective, and possibly better than the current (standard) treatment. These types of studies evaluate new drugs, different combinations of existing treatments, new approaches to radiation therapy or surgery, and new methods of treatment.
Teenagers who participate in clinical trials are often among the first to receive new treatments before they are widely available. However, there is no guarantee that the new treatment will be safe, effective, or better than a standard treatment.
Clinical trials have already helped doctors find effective treatments for many types of cancer that are common for teens. To take advantage of these newer treatments, teens with cancer should be treated at a specialized cancer center. These centers actively participate in the development of new treatments and offer patients the opportunity to participate in clinical trials. The Children's Oncology Group (COG) runs large clinical trials for children and teens with cancer.
Clinical trials are carefully reviewed to protect the rights and safety of people who enroll. To join a clinical trial, you and your parents must participate in a process known as informed consent. During informed consent, the doctor will talk about all of the treatment options so that you and your parents understand how the new treatment differs from the standard treatment. The doctor must also tell you about the risks of the new treatment, which may or may not be different from the risks of standard treatment. Finally, the doctor must explain what will be required of each patient in order to participate in the clinical trial, including the number of doctor visits, tests, and the schedule of treatment. It is also important to keep in mind that you may stop participating in a trial at any time.
Informed consent is an ongoing process between you and the doctors and nurses that allows you to ask questions, discuss your concerns, and learn about any new information related to the particular trial or therapy. It's important for you to ask as many questions as you need to understand what it means to participate in the clinical trial. If you are under 18 years old, your parents must legally give consent for a clinical trial. However, you will also be asked to give informed assent. When you give informed assent, it means that you understand what will happen in the study and that you agree to participate.
Clinical trials are done in different phases, and each phase has a different goal. Talk with your doctor about what phase the clinical trial is in and what to expect. The goal of a phase I trial is to prove that a new treatment may be given safely to people. In a phase II trial, the goal is to find out more about the safety and effectiveness of the new treatment. A phase III trial involves many more people (hundreds to thousands) and takes several years. In a phase III trial, a new treatment that was used to effectively treat a small number of patients is compared with the current, standard treatment for that type of cancer. After a successful phase III trial, an application is submitted to the U.S. Food and Drug Administration (FDA) for approval to sell the new treatment.