A clinical trial is a research study designed to evaluate a new treatment approach. Clinical trials are the only way new treatments can emerge that improve the lives of people with cancer.
A clinical trial often starts with a scientific idea, based on the results of laboratory research. The researchers who bring forth these ideas usually work in cancer centers, universities, hospitals, community clinics or pharmaceutical company labs.
There are many types of oncology clinical trials, including treatment, screening, prevention, symptom management and quality of life. This booklet focuses on cancer treatment trials. While this booklet primarily refers to treatment trials that evaluate drugs, it is important to note that other treatment methods, including surgery and radiation, are also evaluated in clinical trials.
Most often, clinical trials test an already-approved drug, for use in a different way. Other trials evaluate a drug (or a combination of drugs) not previously given to humans, to make sure the approach is safe and will provide benefit to patients.
Many researchers and doctors study a new drug in the laboratory before a human clinical trial is designed and proposed. Among other things, they want to know how the drug is absorbed into the body, how long it remains in the body and whether it should be given by mouth or intravenously (through a needle into a vein).
Once the laboratory research is complete, researchers and doctors create a Clinical Protocol, a detailed “blueprint” of every aspect of the trial. The clinical trial sponsor then submits an Investigational New Drug (IND) application and the Clinical Protocol to the U.S. Food and Drug Administration (FDA). The FDA has 30 days to review the IND and Clinical Protocol to both provide input and to assure that trial participants will not be subjected to unreasonable risk. (A clinical trial sponsor is a person, group, company, institution, organization or government agency that oversees or pays for a clinical trial, and collects and analyzes the data.)
When discussing your treatment options with your oncologist, ask if a clinical trial might be right for you. Clinical trials are routinely integrated into the treatment plan for people with cancer.
Here a few things to consider:
Most clinical trials are designed to test a new treatment approach to find out whether the approach has any added benefit, compared to current treatment approaches.
Often, people who take part in clinical trials gain access to and benefit from new treatments that are not otherwise available.
All clinical trials have eligibility requirements, and you may or may not qualify to participate in any specific trial.
Before you participate in a clinical trial, you will be fully informed of the risks and benefits of the trial, including any possible side effects.
You have the right to stop taking part in a clinical trial at any time for any reason. The “Resource” section of this booklet provides websites that allow you and your doctor to search for a clinical trial that might be right for your individual circumstances, including your type of cancer and your geographic location.