clinical trials management system
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10-02-2010, 06:52 AM
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Clinical trials are done to see if a new drug or device is safe and effective for people to use. Clinical trials are also done for other reasons such as comparing existing treatments to determine the better one. The current, approved treatments are called the "standard treatments." Sometimes clinical trials are used to study different ways to use the standard treatments so they will be more effective, easier to use, and/or decrease side effects. Sometimes, studies are done to identify the best treatment among different population, such as children, for whom the treatment was not tested previously.
For most trials, researchers, doctors, and other health professionals administer the clinical trials according to strict rules set by the Food and Drug Administration (FDA). FDA sets the rules to make sure that people who agree to be in studies are treated as safely as possible.
There are many different kinds of clinical trials, including:
Trials that test new treatments, new combinations of drugs, or new approaches to surgery or radiation therapy.
Prevention trials, that looks for better ways to prevent disease in people who have never had the disease or to prevent a disease from returning. These approaches may include medicines, vitamins, vaccines, minerals, or lifestyle changes.
Diagnostic trials that are conducted to find better tests or procedures for diagnosing a particular disease or condition.
Screening trials to test the best way to detect certain diseases or health conditions.
Quality of Life trials (or Supportive Care trials), that explore and measure ways to improve comfort and the quality of life for individuals with a chronic illness.
Usually, clinical trials compare a new product or therapy to something else to see if it works as well or better to treat or prevent a disease or condition. In a blinded study, a participant may be randomly assigned to receive the test product, or an existing, approved therapy.
This Project deals with new drugs to see if it works as well or better to treat or prevent a disease or condition. The Clinical Research Associate generates the reports on the observations done by the doctors.