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P1072a ABC Clinical Trials GTG

5 Will participating in a clinical trial benefit or harm me? Even with IRB review and informed consent, there is no guarantee that participating in a clinical trial will benefit you personally, or will not produce any undesirable effects. In fact, clinical trials should always be designed to give you the best therapy possible while testing a new therapy to see if it is better than what is currently being used. Before agreeing to participate in a clinical trial, be sure that you question your doctor to explain the study in detail. You should understand everything being asked of you and all of the potential risks. Also, if you decide not to participate in the trial, you will still have all the same treatments available to you and continue to receive the best care your physician has currently available. How do clinical trials work? Your doctor will closely follow the protocol for the clinical trial. A protocol is the term used for the “recipe” for a clinical trial. This tells your doctor exactly what study treatment to give you (ingredients), how much to give you (measurements), and when to give it to you (timing). The protocol also tells your doctor what tests to give you, and how often to give them to you. After the trial is complete, all of the information is collected and analyzed to determine if the new treatment is better, worse, or about the same as the standard treatment. How are people who participate in clinical trials protected? Medical treatments such as drugs or vaccines must be tested before they can be sold by prescription or over the counter. Clinical studies are also needed for medical devices such as hip replacements, stents, pacemakers and in-home diagnostics like blood pressure or blood glucose testing machines. The Food and Drug Administration (FDA) sets very strict rules on how these treatments must be tested before they can be sold to the American public. Before doctors can conduct any research on human beings, they must have the research approved by an Institutional Review Board (IRB). An IRB may include community representatives, scientists, clergy, physicians, and attorneys, whose sole purpose is to make sure that you, as a potential research participant, will not undergo any unnecessary or harmful tests and procedures. In addition to having the research approved by an IRB, your doctor must explain the study and ask your permission, known as informed consent, before you enroll in a clinical trial. What is informed consent? Informed consent is a process that protects you by guaranteeing that you are provided as much information as you need to ask questions and fully understand the possible benefits and risks associated with participating in the clinical trial. Because of informed consent, you don’t need to worry about being in a research study of an experimental treatment without your knowledge. The FDA strictly prohibits such secret experiments and is very serious with respect to your safety.


P1072a ABC Clinical Trials GTG
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