Clinical trials are research studies in people that answer a specific medical question. They test new treatment and prevention methods to find out if they are safe, effective, and better than the current treatment. 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.

Phases and sponsorship

There are three types of treatment trials, called phases:

• When a new treatment is first tried in people in a phase I trial, the objective is to determine a safe dose and formulation. 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. In addition, the doctors collect additional safety information about the treatment. 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 newest one 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.

Clinical trials can be sponsored by the government agencies, such as the National Cancer Institute (NCI), or hospitals, pharmaceutical companies, and health organizations. For young adults with cancer, a good resource for clinical trials is a cooperative group. Cooperative groups are large networks of doctors and other health care professionals from many different institutions that develop and coordinate clinical trials with funding by the NCI. Find a cancer center or cooperative group.

Participating in a clinical trial

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. Because cancers that occur in young adults can be different from the same cancers in children or adults, it is important to consider participating in a clinical trial. Nearly every treatment that is available today is a result of 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 clinical trials conducted by the Children's Oncology Group (COG). Talk with your doctor about finding a clinical trial and read stories about patients who have participated in clinical trials.

The costs of a clinical trial vary by state and may depend on what costs the sponsors and/or the insurance company covers. Some clinical trials offer the participants reimbursement for related expenses, such as the cost of getting to the clinical trials site, and some offer payment, but many do not. Talk with your doctor about the costs of clinical trials.

Safety

The safety of the patients is extremely important in clinical trials. Clinical trials follow a rigorous review and oversight process that is designed to protect the rights and safety of the people who enroll. 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

Clinical Trials

Cancer in Young Adults