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Clinical Trials: BackgroundWhat are clinical trials?Before a new drug or new treatment is approved by the U.S. Food and Drug Administration (FDA), it must be shown to be both safe and effective. Typically, this is accomplished via clinical trials -- carefully controlled studies designed to test and evaluate new drugs and new treatment plans. These trials are carried out to learn more about the new treatment and to find better therapies. Why do people participate in clinical trials?People may be interested in clinical trials for a variety of reasons. Some people who are very sick or are not responding to standard treatments join clinical trials in order to receive new, investigational treatments. They are hoping that this treatment -- possibly a new drug or a new combination of drugs -- will work better for them than standard therapy. This is not always the case as new treatment strategies may not work or may have side effects. For this reason, all people in clinical trials are carefully monitored. Frequent medical exams and tests are performed to assure their safety. Other people participate in clinical trials to contribute to medical science and to help doctors and researchers find better ways to help others. Related links Who Should Take Part in a Clinical Trial Protecting Participants in Clinical Trials Why Volunteer for a Clinical Trial The content on this page was written by Dr. Marc Engelsgjerd and Michael D'Agostino of Veritas Medicine |
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