Frequently Asked Questions about Clinical Trials
by Victoria Ruffing, RN
Research Nurse in the Johns Hopkins Arthritis Center
- What is a clinical trial?
- Why should I take part in a clinical trial?
- What are the benefits of taking part in a clinical trial?
- What are the risks of taking part in a clinical trial?
- How do I know if I have been given all the information I need about taking part in a clinical trial?
- What if I decide that I don't want to be a part of the study, even though the study has already started?
- Who takes part in clinical trials?
- Is it safe to take part in a clinical trial if I am pregnant or trying to get pregnant?
- How can I find out about clinical trials in my area?
A clinical trial is a type of research study. Clinical trials test a new treatment and compare it to the available treatment (the usual way doctors treat a certain health condition or disease). For example, a clinical trial might study how well a new medicine helps people with cancer or if certain foods help people stay healthy. The Food and Drug Administration requires clinical trials before a new medication can be approved. Sometimes it is necessary to compare an experimental treatment with a placebo (inactive treatment) when no standard treatment exists.
Why should I take part in a clinical trial? I don't want to be a guinea pig.
There is a great need for people to take part in clinical trials. We need to learn more about arthritis and its causes. As more people take part in clinical trials, researchers can learn more about diseases and develop better treatments.
What are the benefits of taking part in a clinical trial?
Because the trials are experiments, personal benefit cannot be guaranteed. The benefits of taking part in a clinical trial depend on the study you join. The benefits also depend on which group within the study you are assigned to. Here are some possible benefits you might get from taking part in a clinical trial. You may:
- get free health exams;
- learn more about your health;
- take a more active role in your own health care;
- have your health watched closely;
- receive some medications at no cost to you; and
- help answer research questions that may mean better health for people in the future.
What are the risks of taking part in a clinical trial?
There are risks to you when you take part in a clinical trial. The study doctors and coordinators will watch you carefully for any changes in your health. You are always free to leave the study. The risks will vary depending on the kind of trial you join. Here are some possible risks.
- You may have side effects (health problems) from taking a new medicine or getting a new procedure that is being tested.
- There may be side effects that are unexpected.
- Usually you will need to give blood samples. Some people find that process uncomfortable.
- The visits for the clinical trial may be frequent and time consuming.
- The therapy you receive may not be effective or you may be assigned to a placebo group.
How do I know if I have been given all the information I need about taking part in a clinical trial?
When beginning any study the doctor, or investigator, must ask approval from an Institutional Review Board (IRB). The IRB is a committee of doctors and other medical personnel that have no ties to the study. The IRB makes sure the study is as safe as possible and that the “informed consent” explains all of the important information to the patient.
Before people join a clinical trial, they go through something called the "informed consent process". The informed consent process means that you are given written information that tells you about the purpose of the study; risks and benefits of being in the study; and what will happen to you in the study. You will be given an informed consent form, which you will need to read over very carefully. Take the form home and share it with family members, friends, and your primary care doctor. Once you have read the form, ask questions about words or procedures that you don't understand.
Another part of the informed consent process is that you can ask questions about the study at any time. It is your right to have all the information you need to make your decision about whether or not to take part in a clinical trial. Don't let anyone pressure you into taking part in a clinical trial. The choice is yours.
That's okay. You can change your mind and leave the study at any time. Remember that being a part of a clinical trial is always your choice. Your relationship with your doctor will not change because you decide to leave the study. Your care will not be affected in any way.
Who takes part in clinical trials?
Many different people take part in clinical trials. People who take part in clinical trials are volunteers who meet eligibility criteria for the study. Eligibility criteria are requirements that someone must meet to be a part of the study. Some examples of eligibility criteria are having a certain disease such as rheumatoid arthritis; not showing improvement on standard arthritis medications; being a certain age; or being in good health. These criteria help make sure that the study answers the right research question.
Is it safe to take part in a clinical trial if I am pregnant or trying to get pregnant?
Generally, no, but check with your doctor or the study coordinator to find out if it is safe to take part in a clinical trial if you are pregnant or trying to get pregnant. There is concern about how medicines used in a study can affect a woman's unborn baby. The informed consent form should tell you if any of the medicines in the study could affect your unborn baby. Also you need to know if it is okay to breast feed your baby while you are taking part in a clinical trial. Don't be afraid to ask questions about safety. It is your body, your baby, and your decision to make.
How can I find out about clinical trials in my area?
If you are interested in taking part in a study, call the research study office. The research staff will ask you questions to see if you meet the eligibility criteria for that study. If you meet the criteria, you will get an informed consent form that explains the study and be able to ask questions about the study. The decision to take part in a clinical trial is yours to make.
Information about clinical trials in arthritis at the Johns Hopkins Arthritis Center.