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A clinical trial is a test of a drug, vaccine, or other medical treatment on human beings. Clinical trials do not begin until tests on animals have suggested the treatment is safe. But since animals may react differently to a drug than humans will, testing on people is essential if the drug is ever to be manufactured and sold for human use.
Clinical trials of a drug's effects and effectiveness on humans occur in several phases. A Phase I trial tests a drug on twenty to eighty people to determine its safety, pinpoint the ideal dosage, and identify any negative side effects. A Phase II trial tests a drug on 100 to 300 people to see if it does what it was designed to do. This second testing phase also provides additional opportunities to determine the drug's safety. A Phase III trial tests a drug on 1,000 to 3,000 people to confirm that it is effective, and to compare its effectiveness and side effects to other treatments of the same condition, disease, or disorder. If the results of the trials are positive, then the U.S. Food and Drug Administration (FDA) will approve the drug. The company can then sell it to the public.
People who work in clinical trials design the testing program, including patient surveys, consent forms, and other documents. They work with the doctors and nurses who monitor and care for the patients to make sure the correct procedures are followed. Workers also collect data from the trial and analyze it to see if the medical treatment works or not. Jobs related to clinical trials include clinical research associate, clinical coordinator, clinical data manager, and clinical programmer. These positions generally require bachelor's degrees.
Clinical programmers design and build computer databases to hold all the information gathered during a clinical trial. The health of patients may be followed for months or years. At each study session, patients may undergo several medical tests and fill out surveys about their health. Clinical programmers make sure that information from each phase of the trial gets entered in the study databases. They also analyze the data and resolve problems with it or the database.
Clinical trials are important in making sure that a drug is safe and effective before many patients begin to use it. As long as companies continue to create new drugs, clinical trial workers will continue to be needed.
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