Before deciding to participate in a clinical trial, you should know as much as possible about the study. It is important for you to feel comfortable asking questions, and the staff should answer them in a way that you can easily understand.

Plan before the appointment. For example, write down the questions you want to ask, ask a friend or relative to come with you for support and to hear the responses to your questions, or bring a tape recorder so you can replay the discussion after you get home.

Questions about the research

• Why is this research being done?
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• What is the purpose of the study?
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• Who is sponsoring the study?
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• Who has reviewed and approved this study?
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• Why does the research team think the treatment, drug, or medical device will work?

Questions about your participation in the study

• Where is the study taking place (sometimes called the study site)?
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• How often will I have to go to the study site?
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• How long will the study last?
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• What kinds of therapies, procedures, and/or tests will I have during the study?
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• Will they hurt? If so, for how long?
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• Will I be able to take my regular medications during the study?
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• What medications, procedures, or treatments must I avoid while in the study?
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• Will I have to be in the hospital during the study?
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• How will the tests in the study compare to tests I would have outside the study?
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• What are my responsibilities during the study?
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• Will the study researchers work with my doctor while I am in the study?
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• Who will provide my medical care after the study ends?
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• Can anyone find out that I am participating in a study?
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• Can I talk to other people in the study?
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• Will I be able to find out the results of the study?
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• What other treatment options do I have?

Questions about risks and benefits of the clinical trial

• How do the possible risks and benefits of the study compare with approved treatments for me?
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• What are the possible immediate and long-term side effects?

Questions related to the cost of a clinical trial

• Will I have to pay to participate in the study?
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• What are the charges likely to be?
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• Is my insurance likely to cover those expenses?
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• What other ways can I get my expenses paid?