Taking a Look at Clinical Trials

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Every medical innovation starts with an idea or vision, and goes through several developmental stages, namely, basic research, translational research and clinical research before being able to market the treatment. (4) This treatment can be a drug, a medical device, a vaccine, a blood product or gene therapy. (3) The basic research is done in a laboratory, where cell function is studied, and it is determined under what conditions the treatment could cause cells to function more effectively. The treatment is then tested in animals to see the effect, and to test possible toxicity. Once the treatment has been named safe for use in animals, it can then be tested in humans. (4) Clinical research, or clinical trials, involves the testing of the treatment in human volunteers, working towards the approval of the treatment to be marketed. (3) The research that bridges the gap between studies done in the laboratory and clinical trials is then known as translational research. (4) The main purpose of a clinical trial is to determine if the treatment is safe and effective for human use, and is required by the Food and Drug Administration (FDA) before a treatment can be approved. There are, however, other reasons these trials are performed. They can be used to compare the new treatment to an already existing one to determine which is more effective, and to determine different ways in which to use current treatments in order for them to be most effective, easiest to use and provide the
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