Clinical trials are designed to test treatments under very specific scientific and ethical guidelines. Each study follows an action plan (in clinical trials, called a "protocol") that explains how many people will participate in the study, who is eligible to participate, what study drugs participants will take, what medical tests will be administered and how often, and what information will be gathered. The FHCI uses the same research clinical trials as all research centers participating in a particular study in the world.
Clinical trials are conducted in the investigator's office. When the investigator has identified a clinical trial as an appropriate treatment option, a Clinical Research Center registered nurse is notified to determine the patient's eligibility for the trial. The specific type or stage of cancer usually determines eligibility.
Once eligibility is established, the investigator, along with a research registered nurse, will explain the informed-consent process, one of the patient's most important rights in the research process. It outlines the purpose of the study, the exact treatment that will be administered, all possible side effects, and the patient's right to withdraw from the study at any point. Signing the consent form acknowledges that the trial was explained and is understood.
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