What are the risks involved in clinical trials?

    The potential risks of participating in a clinical trial may include the following:

The clinical trial may require more time than a non-clinical trial treatment such as more visits to the clinical trial site, more treatments, hospital stays, etc.

There may be unpleasant, serious or life threatening side effects to experimental treatments.

    You should discuss with your doctor and carefully consider the potential benefits and risks of participation in a clinical trial. If you qualify to participate in a clinical trial, the decision to participate is yours to make. A medical ethics committee oversees the clinical trial to ensure all participants are appropriately treated. If you are eligible and choose to participate in a clinical trial, an informed consent document will be presented to you. The informed consent document includes detailed information about the clinical trial, what you can expect as a participant and the potential benefits and risks associated with the clinical trial. If you are dissatisfied at any time during the conduct of a clinical trial, you are free to leave the clinical trial.

You may also want to check out our marketing trials. Product testing pays less, but has far fewer risks.

What questions should I ask if offered a clinical trial?

    If you are offered a clinical trial, feel free to ask any questions or bring up any issues concerning the trial at any time. The following suggestions may give you some ideas as you think about your own questions.

The study

What is the purpose of the study?
Why do researchers think the approach may be effective?
Who will fund the study?
Who has reviewed and approved the study?
How are study results and safety of participants being checked?
How long will the study last?
What will my responsibilities be if I participate?

Possible risks and benefits

What are my possible short-term benefits?
What are my possible long-term benefits?
What are my short-term risks, such as side effects?
What are my possible long-term risks?
What other options do people with my disease have?
How do the possible risks and benefits of this trial compare with those options?

Participation and care

What kinds of therapies, procedures and /or tests will I have during the trial?
Will they hurt, and if so, for how long?
How do the tests in the study compare with those I would have outside of the trial?
Will I be able to take my regular medications while in the clinical trial?
Where will I have my medical care?
Who will be in charge of my care?

Personal issues

How could being in this study affect my daily life?
Can I talk to other people in the study?

Cost issues

Will I have to pay for any part of the trial such as tests or the study drug?
If so, what will the charges likely be?
What is my health insurance likely to cover?
Who can help answer any questions from my insurance company or health plan?
Will there be any travel or child care costs that I need to consider while I am in the trial?
Tips for asking your doctor about trials

Consider taking a family member or friend along, for support and for help in asking questions or recording answers.
Plan ahead what to ask — but don't hesitate to ask any new questions you think of while you're there.
Write down your questions in advance, to make sure you remember to ask them all.
Write down the answers, so that you can review them whenever you want.
Ask about bringing a tape recorder to make a taped record of what's said (even if you write down answers).

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