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DURATION Up to 1 month Several months Several years Ongoing (following FDA approval)
POPULATION Healthy volunteers or individuals with Individuals with target disease Individuals with target disease Individuals with target disease, as well
the target disease (such as cancer or HIV) as new age groups, genders, etc.
SAMPLE SIZE 20 to 80 200 to 300 Hundreds to thousands Thousands
EXAMPLE Study of a single dose of Drug X in normal Double-blind study evaluating safety Study of Drug X vs. standard Study of economic benefit of newly-
subjects and efficacy of Drug X vs. placebo in treatment in hypertension study approved Drug X vs. standard
patients with hypertension treatment for hypertension
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Issued: 9/29/09 Last Reviewed: 9/29/09
Effective: 9/29/09 Last Revised: 9/29/09
Form #: 712