Frequently Asked Questions for Patients

What are clinical trials?   Clinical trials, or research studies, use patient volunteers to help investigate different ways to treat disease. Clinical trials involve the use of investigational drugs (also known as study drugs) and drug delivery methods to determine if a study drug or delivery method is safe and effective. Why are clinical trials important? Clinical trials contribute to the overall knowledge and progress made in developing new therapies. Patients who agree to participate may possibly benefit from the research study, while receiving the best current standard treatment as well. How do clinical trials work? Clinical trials are structured into four phases: In Phase I clinical trials, researchers test a study drug in a small group of people (20 to 80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects. In Phase II clinical trials, the study drug is tested in a larger group of people (100 to 300) to measure its effectiveness and further evaluate its safety. In Phase III clinical trials, the study drug is tested in large groups of people (1,000 to 3,000) to confirm its effectiveness, monitor side effects, compare it to approved standard treatments, and collect information that will allow the study drug to be used safely. In Phase IV clinical trials, the drug is tested after it has been marketed to collect information about its effect in various populations and about any side effects associated with long-term use. What is a trial like for patients? If the patient is eligible and agrees to participate, he or she is assigned randomly either to receive the current standard treatment, or the current standard treatment and the study drug regimen. If no standard treatment is available, a trial may compare the study drug to a placebo, which is similar to the study drug, but contains no active ingredient. During a trial, patients are treated and monitored by a team of health care professionals. This team will give the patient specific instructions about the trial and about additional tests and doctors visits that might be required and any related costs. Throughout the clinical trial, patients come first. If there is no improvement or you experience intolerable side effects, you and your physician can decide to discontinue trial participation and resume other treatment options. Should you do so, your decision will be respected without any effect on future treatment plans. Why do cancer patients choose to participate in clinical trials? Some may hope to assist in finding a cure or seek a longer life or a way to feel better. Others find that the current standard therapies are not optimal for their cancer and wish to be among the first to participate in a research study and receive an investigational drug. Whatever the reason, participation could make a difference in a patient's future, as well as in the lives of future cancer patients. How do I know if I should participate in a clinical trial? The decision to participate in a clinical trial is one that only you can make, with the help of your physician and the people close to you. Through a process called “informed consent”, you will learn the key facts about a particular clinical trial before making a decision about participating. Your doctor will explain the purpose and requirements of the study, including any potential drawbacks and benefits. If you agree to take part in the trial, you will be asked to review and sign a form that outlines the study's objectives, risks and financial details prior to participating. If the investigational drug is proven to be effective, you may be among the first to benefit. In addition, through your participation in a research study, you will be helping future cancer patients. Are there risks involved in participating? Because clinical trials are research studies, study drugs may be no better than current standard drugs or treatments. In addition, you may experience side effects that are worse than those of current standard drugs and treatments. Also, your health insurance company may not cover all of the costs associated with a clinical trial. All of these factors should be discussed thoroughly with your physician and those close to you before deciding whether or not to participate in a clinical trial. How do I learn about specific clinical trials? Clinical trials may be available right in your own community. Ask your physician for specific information or search the US Oncology clinical trial list to find a current US Oncology trial in your region.

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