Many teens who have cancer are treated as part of a clinical trial, which is a way to test a new treatment to prove that it is safe, effective, and possibly better than a standard treatment. People who participate in clinical trials are 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. In this section, you’ll learn more about clinical trials, including:

• The purpose of clinical trials
  
  
• The rights and responsibilities of a person in a clinical trial
  
  
• The different types of clinical trials

The treatments studied in clinical trials can include new medications, new combinations of existing treatments, or new methods of treatment.

The purpose of a clinical trial is to answer a specific medical question in a highly structured, controlled process. Treatment clinical trials study whether a new treatment is safe and effective. Those who chose to participate in a clinical trial receive one of two treatments: either the standard treatment or the new one that is being studied. Many hospitals and cancer centers actively participate in the development of new treatments and offer their patients the opportunity to participate in clinical trials. One of the largest organizations is the Children's Oncology Group (COG), which runs most of the clinical trials for children and teens with cancer.

Safety

Clinical trials follow a thorough review and oversight process that is designed to protect the rights and safety of people who enroll in clinical trials. The design of a clinical trial is carefully reviewed by medical professionals as well as other people in the community.

To join a clinical trial, parents and children must participate in a process known as informed consent. During informed consent, the doctor will talk about all of the treatment options, so the person understands 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 withdraw from a trial at any time and that your doctor will always have your well-being as the first priority.

The informed consent process 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 that is related to the particular trial or therapy.

Phases

Clinical trials are done in different phases:

• The goal of a phase I trial is to prove that a new treatment, which has proven to be safe for use in animals, may also be given safely to people. Doctors collect data on the dose, timing, and safety of the treatment. A phase I trial usually lasts several months and involves between 10 to 20 people.
  
  
• A phase II trial is designed to provide more detailed information about the safety of the new treatment and to find out how well it works for treating a specific type of cancer. A phase II trial takes about two years to complete and involves 20 to 40 people.
  
  
• A phase III trial takes a new treatment that was used to effectively treat a small number of patients with cancer and compares it with the current, standard treatment for that disease. These clinical trials are usually randomized, meaning that patients are assigned by chance (similar to a flip of a coin) to receive either the investigational treatment or the standard treatment. A phase III trial involves hundreds to thousands of people and take several years. Once a treatment has been proven successful in a phase III trial, an application is submitted to the U.S. Food and Drug Administration (FDA) for approval to sell the new 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. Not only do doctors at these centers have extensive experience in treating teens and have access to the latest research, the centers often have extra support services, such as nutritionists, social workers, and counselors.

More Information

Cancer.Net Podcast: What Are Clinical Trials?

Finding a Clinical Trial

Cancer in Teens

Additional Resources

Teens Living With Cancer: Clinical Trials