Many teens who have cancer are treated as part of a clinical trial, which is a research study that compares standard treatments (the best treatments available) with newer treatments that may be more effective. 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. Learn more by listening to the Cancer.Net Podcast: What Are Clinical Trials?

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 rigorous 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.

Beyond these checks and balances, research institutions are required to obtain informed consent from every person in the clinical trial. The informed consent document provides you with written information on all aspects of the clinical trial and tells you about the possible risks as well as benefits. For example, you have the right to know and understand the type of treatment you will receive. A member of the team will also review what it means to be a participant in a treatment trial and go over your rights and responsibilities. You need to know 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. Read more about informed consent.

Phases

Clinical trials are done in different phases:

• Phase I trials prove that a new treatment, which has proven to be safe for use in animals, also may be given safely to people. Doctors collect data on the dose, timing, and safety of the treatment. Phase I trials usually last several months and involve between 10 to 20 people.
  
  
• Phase II trials are designed to provide more detailed information about the safety of the new treatment and to determine how well it works for treating cancer. Phase II trials take about two years to complete and involve 20 to 40 people.
  
  
• Phase III trials take a new treatment that was used to effectively treat a small number of patients with cancer and compare it with the current, standard treatment for that disease. Phase III trials involve 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. Doctors at these centers have extensive experience in treating teens and have access to the latest research and often have extra support services, such as nutritionists, social workers, and counselors. Find a clinical trial.

For More Information

Clinical Trials

Cancer in Teens

Additional Resources

Teens Living With Cancer: Clinical Trials