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.
- What is the purpose of the study?
- Who is going to be in the study?
- Why do researchers believe the experimental treatment being tested may be effective? Has it been tested before?
- What kinds of tests and experimental treatments are involved?
- How do the possible risks, side effects, and benefits in the study compare with my current treatment?
- How might this trial affect my daily life?
- How long will the trial last?
- Will hospitalization be required?
- Who will pay for the experimental treatment?
- Will I be reimbursed for other expenses?
- What type of long-term follow up care is part of this study?
- How will I know that the experimental treatment is working? Will results of the trials be provided to me?
- Who will be in charge of my care?
What kind of preparation should a potential participant make for the meeting with the research coordinator or doctor?
- Plan ahead and write down possible questions to ask.
- Ask a friend or relative to come along for support and to hear the responses to the questions.
- Bring a tape recorder to record the discussion to replay later.
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.
Yes. Most clinical trials provide short-term treatments related to a designated illness or condition, but do not provide extended or complete primary health care. In addition, by having the health care provider work with the research team, the participant can ensure that other medications or treatments will not conflict with the protocol.
Keep in mind that participating in clinical research is not the same as seeing your doctor. Here are some differences:
Participating in Clinical Research: The researcher's goal is to learn about your illness.
Seeing Your Doctor: Your doctor's goal is to treat your condition.
Participating in Clinical Research: The researcher must use standardized procedures. You will probably be removed from the study if your illness worsens.
Seeing Your Doctor: Your doctor will change your treatment as necessary.
Participating in Clinical Research: You will be randomly assigned to a group taking a standard treatment or placebo, also known as an inactive pill (control group), or a group taking a new treatment (treatment group).
Seeing Your Doctor: Your doctor will usually offer standard treatment for your illness.
Participating in Clinical Research: The results from your participation may help researchers develop new treatments and may be published so that other researchers can learn.
Seeing Your Doctor: Your treatment is designed to help you, not to help the doctor learn how to treat people with your illness.
Participating in Clinical Research: In some cases, costs of the study may be covered, and you may receive additional compensation.
Seeing Your Doctor: You will likely need to pay or use insurance for treatment.
Participating in Clinical Research: With your permission, researchers may check in with your doctors to learn about your conditions and past treatments.
Seeing Your Doctor: Your doctor usually won't share your information with researchers. (In some cases, he or she may ask permission to share information).