Christine R Hartel

Clinical Research In the process of developing new drugs, pharmaceutical companies must perform rigorous studies in the laboratory, in animals, and then, if the drug looks promising, in humans. Carefully designed research into the safety and effectiveness of a drug in humans is called CLINICAL RESEARCH (or CLINICAL TRIALS). Research resulting from new surgical techniques, medical devices, and other medical treatments also fall under this heading.

To conduct research in humans, approval must be obtained from the Food and Drug Administration (FDA). The research sponsors (usually the pharmaceutical company) submit a detailed application termed an Investigational New Drug Application that summarizes the drug characteristics, manufacturing process, and results of any laboratory and animal studies. In addition, this application provides detailed information regarding proposed studies in humans, including the research protocol, data collection documents, and informed consent form. If the drug is proven to be safe and effective, the sponsors can submit a voluminous application called a New Drug Application to the Food and Drug Administration. This application contains the material in the Investigational New Drug Application as well as the data, analyses, and conclusions of all of the clinical trials conducted.

Clinical trials of drugs or medical devices progress through four phases. Phase I studies are conducted on healthy volunteers to assess the safety of the drug or device. Phase II studies are conducted on a relatively small group of patients with the target disease to assess effectiveness as well as safety. Phase III studies are conducted on a large group of patients with the target disease to confirm effectiveness, observe side effects, and to compare the test treatment to the standard treatment. Phase IV studies are performed for a variety of reasons after the drug or device has been on the market. Reasons for conducting phase IV studies include: to test the treatment in different populations (e.g., in children or the elderly), to assess the effects of long-

term use of the treatment, or to use the treatment on a different target disease.

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