INFO: Questions to Ask before Joining a Clinical Trial - Clinical Trial FAQ

[Guest guest]

Questions to Ask before Joining a Clinical Trial Article Date: 7/19/2004 Reviewed October 5, 2005 by V. J. , RN, BSN, MA. People should know as much as possible about the clinical trial and feel comfortable asking the members of the health care team questions about it, the care expected while in a trial, and the cost of the trial. The following questions might be helpful for the participant to discuss with the health care team. Some of the answers to these questions are found in the informed consent document. Anyone considering a clinical trial should 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 believe the new treatment being tested may be effective? Has it been tested before? Who will sponsor 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 risk

of cancer or type of cancer 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? How do the possible risks, side effects, and benefits in the study compare with my current treatment? Will I be able to take my regular medications while in the clinical trial? What type of long-term follow up care is part of this study? How will I know that the treatment is working? Will results of the trials be provided to me?

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? Will hospitalization be required? Can I talk to other people in the study? Cost Issues Who will pay for the treatment? Will I be reimbursed for other expenses? 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 When you talk with your doctor or members of the research team: 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. Consider bringing a tape recorder to make a taped record of what's said (even if you write down answers).

Every clinical trial in the U.S. must be approved and monitored by an Institutional Review Board (IRB) to make sure the risks are as low as possible and are worth any potential benefits. An IRB is an independent committee of physicians, statisticians, community advocates, and others that ensures that a clinical trial is ethical and the rights of study participants are protected. All institutions that conduct or support biomedical research involving people must, by federal regulation, have an IRB that initially approves and periodically reviews the research. Source Resource Information. Clinicaltrials.gov. National Institutes of Health. What is a Clinical Trial? National Cancer Institute. National Institutes of Health. Reviewed October 5, 2005 by V. J. , RN, BSN, MA. http://www.hepatitisneighborhood.com/content/treatment_options/clinical_studies_and_research_1979.aspx