A clinical trial is a research study, conducted with patients, designed to evaluate a new medical treatment.
The goal of cancer-focused clinical trials is to find better ways to diagnose, treat and prevent cancer. 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. A clinical trial often evaluates a new drug which has not previously been given to humans, but can also evaluate a new combination of drugs to make sure the approach is safe and will provides 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. Unlike for other medical conditions, 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 against a standard treatment to find out whether the new treatment has any added benefit.
- 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 can stop taking part in a clinical trial at any time for any reason.
The “Resource” tab of this e-booklet lists 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.