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Previous Volume 360:811-813 February 19, 2009 Number 8 Next

	Since this article has no abstract, we have provided an extract of the first 100 words of the full text and any section headings.

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If it were not for the great variability among individuals, medicine might as well be a science and not an art.

— Sir William Osler (1892)

Over the past half century, biomedical science has developed randomized, controlled clinical-trial methods that can distinguish treatment effects from the noise of human variability. Positive results from tests of a treatment in a randomized, controlled trial provide great confidence that an intervention improves a prespecified outcome in a population defined by explicit entry criteria. These methods are rightly venerated because they have helped move medicine from anecdote to science and have largely brought about . . . [Full Text of this Article]

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From the Center for Drug Evaluation and Research, Food and Drug Administration, White Oak, MD.

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