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What is a clinical trial?
Clinical trials are essential to learn about the prevention, diagnosis, and treatment of diseases. Only through the cooperation of scientists, physicians, and volunteers can we learn new ways to treat illnesses.
Before any new drug or treatment is approved by the Food and Drug Administration (FDA) for use in the general public, it must undergo extensive testing to prove its effectiveness and safety. The testing process, know as a clinical trial, may take as long as 10-15 years and involve thousands of research volunteers who take the new study drug or treatment under the close supervision of an investigator (study physician) and research team.
Your rights and safety are protected by an Institutional Review Board (IRB), which must approve each clinical trial protocol before it is conducted at Jacksonville Heart Center. The physicians and lay people on the IRB examine the study to ensure the study patient's rights are protected and that the study described does not pose any unnecessary risk to the study patient.
Who can participate in a clinical trial?
Each study is designed to answer specific questions about the study drug or treatment, so strict entrance guidelines are present for each clinical trial. The entrance criteria vary for each study, but generally include medical history, the disease under study, medications, age, medical test results, and other factors. To be eligible to participate in a study, you must meet the criteria specified by the study protocol.
What is involved in participating in a clinical trial?
The very first step is to have a member of our staff explain the study to your satisfaction. We'll describe the purpose of the study, medical procedures to be done, frequency of study visits, and potential risks and benefits of participating in the study. If after all your questions have been answered, you choose to participate, you will be asked to sign a consent form. Your participation is completely voluntary.
A clinical trial may require more frequent visits to Jacksonville Heart Center than your condition would normally warrant. This is done for your safety as well as to gather information about the new study drug or treatment. Therefore, it is very important to not miss any scheduled study visits.
How do you benefit?
While no direct benefit from study drug or treatment can be promised, the following are potential benefits to participating in a clinical trial:
- The study drug or treatment may be provided at no charge to you
- Study lab tests and procedures may be provided at no charge to you
- You may have the opportunity to try a new therapy before it is available to the general public
- You are helping the scientific community gain important information about a health condition that may benefit you and others in the future
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