Clinical Trials FAQs
Here are answers to some of the most frequently asked questions about clinical trials.
• Will I get a placebo, or a sugar pill, in a clinical trial? In cancer clinical trials, placebos are rarely used. In treatment trials, researchers are usually testing the difference in effectiveness of a new drug or surgical procedure in the experimental group versus the standard treatment in the control group.
• What does randomization in a clinical trial mean? Randomization is a term meaning that when someone is in a clinical trial, there is an equal likelihood that they will be given the experimental or the standard treatment. Besides randomization, a clinical trial is usually blinded, meaning that neither the participant nor the doctor treating you knows who is getting which treatment so the results of the trial are unbiased. Drugs are given numbers and sham surgeries can be performed, but coordinators of the trial know who is getting what to ultimately be able to analyze the data.
• When should I consider participating in a clinical trial? Although many people think participating in a trial when all treatment options have failed, clinicians recommend finding out about clinical trials as early as possible in treatment to have a better understanding of all your treatment choices.
• Will my health insurance cover the costs of the trial? The clinical trial sponsor pays for the costs associated with the treatment under study, such as drugs being compared, and will pay the extra costs associated with additional testing or doctor visits required by the trial’s protocol. Routine patient costs, such as doctor visits, hospital stays, laboratory tests, are the costs of medical care you would have received if you were not in the trial. Some health insurance plans may not cover routine patient care costs in a clinical trial. You should work with the clinical trial research coordinator to help you find out if routine costs are covered by your insurance plan.
• Do I need to be near a major medical center to participate in a clinical trial? No. A major institution may be a coordinator of a clinical trial but under its auspices may have local physicians and community hospitals working with patients, too.
• May I leave a clinical trial? A participant may leave a trial at any time, but should inform the research team about doing so and why.
• Can I participate in a clinical trial that does not study a new treatment? Clinical trials often test treatments, but they also study new diagnostics, screening methods, prevention measures and quality of life improvements, such as ways to reduce side effects of treatment.
• Who runs clinical trials? Clinical trials can be sponsored by pharmaceutical companies, federal agencies, medical institutions, foundations, voluntary organizations and physicians. They can occur in hospitals, universities, doctors’ offices, or community clinics.
• What if I am ineligible for a clinical trial? What other options are available? Under certain circumstances someone might be able to obtain experimental treatments, also called investigational new drugs, if they cannot participate in a clinical trial. The Food and Drug Administration allows manufacturers of investigational new drugs to provide the agents to someone with a serious disease who might benefit from the treatment under what is called “expanded access.” Also, someone might be ineligible for one trial, but be eligible for another one.
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