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WHAT IS A CLINICAL TRIAL?
A clinical trial is a research study to test how well new treatments work in people. When doctors want to learn whether a particular cancer drug, type of surgery, radiation, or combination of treatments is better than what is currently available, they compare treatments in a clinical trial.
WHY CLINICAL TRIALS ARE IMPORTANT?
Clinical trials are the safest and most effective way to examine a new drug or treatment for cancer. Many of today's most useful cancer treatments were studied in clinical trials and proven to be safe and effective. Because of progress made through clinical trials, many people diagnosed and treated for cancer today are living longer than people did just 20 years ago.
People who take part in clinical trials are contributing to cancer research, but they also are helping themselves. By participating in a clinical trial, people with cancer have access to up-to-date medical care from cancer experts, and they receive either promising new treatments or the best available standard treatment for their kind of cancer.
WHAT DO I NEED TO KNOW ABOUT CLINICAL TRIALS
Clinical trials are the final stage of a long, careful research process where scientists first develop and test new ideas in the laboratory. If a new drug or treatment seems promising, scientists then test it in animals to see how it works in a living creature and to see if it has harmful side effects.
When researchers begin to test new treatments in people, the clinical trials are carried out in three phases. Each phase of a clinical trial helps researchers answer different questions about the safety and effectiveness of a new drug or treatment:
Phase I clinical trials help researchers learn the best way to give a new drug or treatment and help them gather information about any harmful side effects.
Phase II clinical trials help researchers discover whether a new drug or treatment has any potential benefits or additional side effects. Phase II clinical trials - which usually involve a small group of people - also help researchers find out the best amount, or dose, of a drug to give.
Phase III clinical trials are the final step and typically involve hundreds of people treated at a number of different medical institutions. In a Phase III clinical trial, researchers compare the new drug or treatment with the current standard therapy. In order to make sure the information collected in a clinical trial is accurate and fair, people are randomly assigned to one of two or more treatment groups (often called "study arms"). One group typically gets the investigational (or experimental) treatment, while the other arm gets current standard treatment.
In some cases, a clinical trial sponsor may elect to conduct a Phase IV clinical trial. Phase IV clinical trials are typically conducted after a drug or treatment has been approved for standard use. Phase IV clinical trials are usually designed to gather additional information (data) about the long-term safety and effectiveness of a drug or treatment.
WHAT IS A CLINICAL TRIAL "PROTOCOL"?
Before beginning a clinical trial, researchers develop a study plan, called a "protocol." The protocol includes specific information about the clinical trial, including:
- Its purpose.
- The number of people and research institutions that will be involved.
- The type of people who will be treated (such as adult men with a specific prostate cancer diagnosis).
- Specific drugs, treatments, tests and procedures that will be used in the clinical trial.
For the safety of people participating in a clinical trial, the protocol must be carefully read and approved by a study's sponsors (such as the National Cancer Institute) as well as by review panels - called Institutional Review Boards (IRBs) - at each medical institution where people will be treated.
WHAT ARE THE BENEFITS AND RISKS OF A CLINICAL TRIAL?
Thousands of people with cancer are helped each year by joining a clinical trial. In many cases, these people choose a clinical trial because they feel the study is their best treatment option. In most cancer clinical trials, people are assured of getting either the investigational treatment or the current standard treatment, which may be as good as or better than the investigational one. Clinical trials allow people to receive medical treatment at leading research institutions under the care of cancer experts. In addition, people who join clinical trials are helping other people with cancer because they are contributing to cancer research. Still, there are risks that people must consider before agreeing to join a clinical trial. Because the trial is designed to answer questions, doctors do not know exactly how it will turn out. It is possible that the investigational treatment may not work as well as current treatment options, and people may experience unpleasant or serious side effects. It is also important to think about the amount of time that will be required for the clinical trial. Clinical trials may involve more time, medical tests, and doctor's appointments than other cancer treatment options would.
HOW ARE PEOPLE PROTECTED?
People who participate in a clinical trial are carefully monitored, and the treatment protocol protects participants in a number of ways. For example:
- If the research team believes you are being harmed by treatment, they will immediately take you out of the trial.
- If researchers learn one of the treatments being studied is not effective or has serious side effects, the trial might be changed or stopped earlier than planned.
- If one treatment is found to be clearly better than the other, all participants in the clinical trial will have the opportunity to be switched immediately to the superior treatment.
HOW MUCH DOES IT COST?
Some clinical trials provide free medications to people participating in a clinical trial, but participants may be responsible for other costs of medical care. Before volunteering, participants should find out whether their health insurance or managed care providers will pay for costs associated with taking part in a clinical trial.
SHOULD I JOIN A CLINICAL TRIAL?
The decision to join a clinical trial for prostate cancer treatment should be made by you and only after you understand all of the potential benefits and risks of a particular clinical trial. Additional questions about participating in a clinical trial should be discussed with your healthcare provider.
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