This Brief discusses key statistical concepts that facilitate the
inferential analysis of data collected from a group of individuals
participating in a pharmaceutical clinical trial, the estimation of
their clinical significance in the general population of
individuals likely to be prescribed the drug if approved, and the
related decision-making that occurs at both the public health level
(by regulatory agencies when deciding whether or not to approve a
new drug for marketing) and the individual patient level (by
physicians and their patients when deciding whether or not the
patient should be prescribed a drug that is on the market). These
concepts include drug safety and efficacy, statistical
significance, clinical significance, and benefit-risk balance.
General
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