Physicians are typically paid on a per-patient basis.The medical care is often provided free to the patient.They typically will get excellent care from the physicians during the course of the study. The patient's rights and safety are protected in two important ways.
Where can you get more information about clinical research?
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Post-Marketing -- Late Phase Three/Phase Four Studies In late phase III/phase IV studies, pharmaceutical companies have several objectives: (1) studies often compare a drug with other drugs already in the market; (2) studies are often designed to monitor a drug's long-term effectiveness and impact on a patient's quality of life; and (3) many studies are designed to determine the cost-effectiveness of a drug therapy relative to other traditional and new therapies. Funding for clinical research comes from both the federal government (through the National Institutes of Health) and private industry (pharmaceutical and biotech companies).
The sponsor of the research hires physicians, who may work in a wide variety of health-care settings, to conduct the clinical trial.
Introduction Before a pharmaceutical company can initiate testing in humans, it must conduct extensive preclinical or laboratory research.
This research typically involves years of experiments in animal and human cells.
This initial phase of testing in humans is done in a small number of healthy volunteers (20 to 100), who are usually paid for participating in the study.
The study is designed to determine what happens to the drug in the human body--how it is absorbed, metabolized, and excreted.
The review board, which is usually composed of physicians and lay people, is charged with examining the study's protocol to ensure that the patient's rights are protected, and that the study does not present an undue or unnecessary risk to the patient.
Second, anyone participating in a clinical trial in the United States is required to sign an "informed consent" form.
This second phase of testing may last from several months to two years, and involve up to several hundred patients. One group of patients will receive the experimental drug, while a second "control" group will receive a standard treatment or placebo.