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- Volunteers
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What Happens in a Clinical Trial? Other Ways Volunteers are Protected
A 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 product 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). 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 than those that already exist. You can also help others better understand how the treatment works in people of different races and genders. What Happens in a Clinical Trial? Clinical trials are done to test whether new products are safe and work against disease. Study products are tested to see how they compare to standard treatments or to no treatment if there is not presently one. Many studies require that neither the patient nor the doctor know whether the patient is receiving the study treatment, the standard treatment, or a placebo (an inactive substance that looks like the drug being tested). In other words, some people may be getting no treatment at all. Studies are done in phases to different kinds of information. Usually, Phase 1 studies include only a few healthy people. Here, scientists find the best way to give a new treatment and how much they can safely give. Phase 2 studies include more than Phase 1 studies , and the people have disease that the product is going to treat. Now scientists try to see how well the product works against the disease. If the product works, the study moves into Phase 3. Here large numbers of patients with the disease are included to see if the new treatment works as well as the standard treatment. Some treatments that are being tested have side effects that can be unpleasant, serious or even life-threatening. Because the treatments being studied are new, doctors do not always know what the side effects will be. Many side effects are temporary and go away when the treatment is stopped. But others can be permanent. Some side effects appear during treatment, while others may not show up until after the treatment is over. The risks depend on the treatment being studied and all known risks should be fully explained to you by the researchers. Informed Consent To help you decide if you want to be in a study, FDA requires that you be given complete information about the study before you agree to take part. This is known as informed consent. FDA requires that people be told:
Before you can be in the study, you must sign the informed consent form, showing that you have been given this information and understand it. The informed consent form is NOT a contract and you can leave the study at any time, for any reason. Other Ways Volunteers are Protected Institutional Review Boards (IRBs) Scientists, doctors and other people from the local community serve on IRBs to review and monitor their hospital's or research institution's medical research involving people. They monitor studies to help make sure that there is the least possible risk to volunteers and that the risks are reasonable in relation to the expected benefits. IRBs make sure volunteer selection is fair and that informed consent is done correctly. Data Monitoring Committees These committees are used mainly when one treatment is being compared with another. These committees are particularly important in tests of treatments for serious or life-threatening disease. These experts review information from studies to make sure they are being done in a way that is safest for the volunteers. During a study, if the committee finds that the treatment is harmful or of no benefit, it will stop the study. If a study shows that one treatment works better than another, the committee stops the study and all volunteers are offered the better treatment. FDA Inspections FDA inspects records and various scientists, clinics, and other research sites involved in a study. The agency does this to make sure volunteers are being protected and studies are being done correctly. From time to time such inspections are done in response to complaints. Here are some questions to ask to your doctor to help you decide if you want to take part in a clinical trial:
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