Postmarketing drug surveillance: an epidemiologic approach

Postmarketing surveillance refers to any means of gathering information about a product after it has been approved for public use. Postmarketing surveillance studies address assorted aspects of beneficial and detrimental adverse drug effects, including the existence of particular causal effects, frequency of and risk factors for certain outcomes, economic consequences of therapy, and characterization of drug use in clinical practice. The primary scientific discipline engaged in postmarketing studies is epidemiology. The principal epidemiologic study designs used in postmarketing surveillance studies are randomized trials, cohort studies, and case-control studies. Regardless of their design, all studies involving human subjects should be conducted by qualified investigators according to a written protocol that has been approved by an institutional review board. Promotional activities conducted under the guise of postmarketing studies are unacceptable.