How are clinical studies regulated?
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A clinical trial is a research study that involves human volunteers to test new methods of screening, prevention, diagnosis, or treatment of a disease. A clinical trial is used to determine if an investigational drug or therapy is both safe and effective. Clinical trials also determine new ways of using existing drugs or therapies. Clinical trials are carefully designed and monitored to ensure the safety of patient volunteers. Clinical trials are required by the Food and Drug Administration (FDA) before any medication can be used by the general public.
Study coordinators and physicians closely monitor the participants throughout the study via physical exams, laboratory tests and other medical procedures. Often, these procedures are described as an extension of what is traditionally done to manage the patient’s health and medical condition. Patients in research studies receive study-medication, tests and exams at no charge throughout the course of the study. Studies can last for weeks, months or even years, during which time patients can save the enormous cost associated with paying for medications and office visits.
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