A Guide to Clinical Drug Research
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Function
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Before selling a drug, a company must test it and the FDA reviews the testing results and the drug. First, a drug must go through laboratory and animal testing. Then human clinical trials are performed.
Features
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Clinical testing takes places in three phases, each involving an increasing number of human test subjects. Phase I contains 20 to 100 participants, Phase II involves up to several hundred test subjects, while Phase III research is conducted on several hundred to thousands of human participants.
Time Frame
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Phase I testing requires six to nine months, Phase II often takes place over several months up to three years while Phase III takes about one to four years of testing.
Considerations
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Ethical and legal codes that govern medical practice are in place with clinical trials to ensure a patient's safety. A clinical trial team will typically consist of physicians, nurses, other health care professionals and social workers.
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