Questions To Ask About A Clinical Trial
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After you and your doctor have decided that a trial might be right for you, the best way to make sure is to learn everything about it you can. This means asking questions lots of questions. You may feel uncomfortable about questioning the researchers, but remember it's your health at stake.
Tips
- Buy a notebook just for writing information about the clinical trial.
- Bring a family member with you for moral support and help in recording what you are told. Or, bring a tape recorder
Here is a list of questions you should ask and get answered. Bring the list with you to the meeting with the researcher(s) and write down the answers. Also write down any other questions you think of so that you will not forget them.
Side Effects
What are the side effects? Be absolutely certain to ask this question before you agree to volunteer. But be aware that some side effects may not yet be known and some may even emerge after the study ends.
Purpose And Expected Results
- What is the study trying to find out?
- What will happen if I enter the study: What might this treatment do to me?
- What are all of my other treatment choices? What are their advantages and disadvantages?
- If you have a chronic condition such as diabetes or hypertension, ask What are the chances that this treatment could make my condition worse?
- What will happen to me if I do not enter the study? What will my condition do if left untreated?
Procedures
- What kinds of tests will I have to take?
- May I have a list of the study rules? Protocol? clarify What will I have to do?
- How much of my time will the study take?
- Can I continue getting the treatment when the study is ends?
- Who do I call if I have more questions?
- Are there any drugs, foods, etc., that I should avoid during the study?
Safety
- Does the trial have an institutional review board (IRB)? If there's no IRB, you probably should not join this study.
- Who is the IRB chair and how is that person reached?
- Has the new drug been used in people before? Has anyone ever been injured by it?
- If I am injured as a result of the study, what treatment will you give me? Who will pay for the cost of injury-related care?
- Will a placebo be used in the study?
- If I don't want a placebo, will you agree to give me either a standard or the new treatment?
- Do any of the researchers have a financial interest in this treatment? (A financial stake in the study’s outcome can cause bias.)
- Who will give me medical care after the study is completed? Who pays for post-study care?
- What kind of follow-up care will I get?
- Will I be able to continue the medicine/treatment after the study ends?
Quality Of Life
- How long will the study last?
- How can the study affect my everyday life? (Will I be nauseous? Tired? Unable to drive?)
- Will I be hospitalized? How often and for how long?
- How often will I have to go to the clinic?
- How many other people are in the study or do you plan to include?
Costs
- Will I have to pay for the treatment or for any other costs such as tests, exams or travel to the clinic?
- If ancillary services are not free, will my health insurance pay for it? (Any investigational treatment should either be free or very minimal cost and any charge for treatment must be approved by the FDA)
Privacy
- Will you protect my privacy by keeping my name secret? How will you do this?
- Who will have access to my records?
Take A Look In The Mirror
There are some important questions you should ask yourself, too:
- Do I want to be in the study, if I might not get the investigational product?
- Based on what is known, do I feel that this treatment is worth the possible risks?
- Can I stick to the study rules?
- Am I doing this for myself or to please my family, my doctor or the researchers?
Don't be afraid to ask any questions that you think of while you talk to the researchers. Keep asking questions until you feel you know enough to make your decision.
After You Ask Your Questions
If you are satisfied with the answers to your questions, fine. Go ahead and sign up for the study if you want to volunteer. But if you do not like the answers you get or if you do not understand them, it's time to talk to your personal doctor again. Tell him or her what is worrying you, and then ask for help in making your decision.