Frequently Asked Questions
What is a Clinical Trial?
"Clinical Trial" is the scientific term for a test or study of a drug or medical device in people. These tests are done to see if the drug or device is safe and effective for people to use. Doctors and other health professionals run the tests according to strict rules set by the Food and Drug Administration (FDA). The FDA sets the rules to make sure that people who agree to be in the studies are treated as safely as possible.
By taking part in a clinical trial, you can try a new treatment that may or may not be better that those already available. You can also contribute to better understanding of how the treatment works in people of different ethnic backgrounds and genders.
Why should Minorities and Women Participate in Clinical Trials?
In the past, most testing of new drugs or medications has been done on white males. This means that some groups, such as African Americans, Hispanic Americans, American Indians, Asian Americans, and women, have not always been included in the tests done on new drugs. But sometimes medications work differently on people in these groups than on white males. So FDA wants people from many different groups included in these studies.
What are the risks?
Many studies require that neither the patient nor the doctor know whether the patient is receiving the experimental treatment, the standard treatment or a placebo (an inactive pill that looks like the drug being tested). In other words, some volunteers may be getting no treatment at all. Some treatments that are being tested have side effects that can be unpleasant, serious or even life-threatening. The risks depend on the treatment being studied and will be fully explained to you in the informed consent material.
What are the benefits?
You will receive a fee each time you come for an appointment which will cover your expenses for travel, child care, and other costs. During the study, you will receive any medications that are part of the clinical trial without any cost to you. In addition, you will have visits scheduled with the doctor to monitor your medical condition, your response to treatment, and check for any side effects which might develop.
Points to remember:
1. Clinical trials are tests of medical treatments to see if they are safe and if they work.
2. Before you agree to take part in a study, you must be given complete information about the study, including possible side effects and benefits.
3. You must sign a special agreement called "Informed Consent" before taking part in the study.
4. You can leave the study at any time.