What is a clinical trial?
A clinical trial is a type of research study. Clinical trials test new treatments and compare them to available treatments (the usual way doctors treat certain health conditions or diseases). 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?
Clinical trials are the engine of medical progress. There is a great need for people to take part in clinical trials. 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. Here are some possible benefits you might get from taking part in a clinical trial. You may: (1) Get free health exams. (2) Learn more about your health. (3) Take a more active role in your own health care. (4) Have your medical condition watched closely. (5) Receive some medications at no cost to you. (6) 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 possible 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 of the possible risks: (1) You may have side effects (health problems) from taking a new medication or getting a new procedure that is being tested. (2) The visits for the clinical trial may be frequent and time consuming. (3) 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 get 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 clinical trial 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." This process ensures that as a potential study participant you are given written information about the purpose of the study, the risks and benefits of being in the study; and what you may expect to occur during the course of the study. Once you have carefully read these documents, you should ask questions about words or procedures that you don't understand.
Can I withdraw from a clinical trial at anytime?
You can change your mind and leave a 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 a study and your care will not be affected in any way.