Clinical trials are research studies that compare standard treatments (the best treatments available) with newer treatments that may be more effective. These treatments can include new medications and procedures, new combinations of existing therapies, new methods of treatment, or better ways to provide psychosocial support and improve the quality of life.

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 therapy is safe and effective, and ultimately better than current therapy. There are three types of treatment trials:

• When a new treatment is first tried in people, the objective of a phase I trial is to determine a safe dose. Phase I trials generally last several months and involve between 10 to 20 people.
  
  
• In a phase II trial, the aim is to find out in what types of cancer the treatment works. Phase II trials take about two years to complete and involve 20 to 40 people.
  
  
• A phase III trial compares the new treatment with current therapy. People who choose to participate in a phase III clinical trial usually receive either the best available treatment or the new one that is being studied. Phase III trials enroll 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.

Many hospitals and cancer centers actively participate in the development of new treatments and offer their patients the opportunity to participate in clinical trials. Most of the trials conducted by a comprehensive cancer center or sponsored by the National Cancer Institute (NCI) are covered by health insurance companies. The experimental drug, if there is one in the clinical trial, is often provided by the government or the drug company. Currently, about 2% of young adults with cancer participate in clinical trials, although many oncologists are trying to make clinical trials more accessible by adjusting the age limits for some studies. Talk with your doctor about finding a clinical trial.

Young adults with cancers that are common in childhood, such as osteosarcoma, Ewing's sarcoma, medulloblastoma, and leukemia, may consider asking about enrolling in pediatric clinical trials conducted by the Children's Oncology Group (COG).

Safety

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

Beyond these checks and balances, research institutions are required to obtain informed consent from every clinical trial participant. 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, 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.

More Information

Cancer.Net: Clinical Trials

Cancer.Net: Cancer in Young Adults