Abstract
Highlighted in this article are several areas of current concern in analysis and interpretation of safety information acquired during observational (ie, nonexperimental) studies. My position is one of enthusiasm for the careful and rational development of this embryonic science of pharmaco-epidemiology into a full-fledged and generally accepted technique for assisting doctors to fulfill their responsibilities to patients.
Doctors must do as much as they can, as soon as they can, and as accurately as they can to assess the efficacy and toxicity of a new drug once it is released in the marketplace.
Spontaneous reporting schemes and the new cohort studies—whether mounted ad hoc by a research group or based on existing record linkage facilities will be discussed. The case-control approach will not be covered—not because it is unimportant—far from it —but rather because it has been carefully evaluated recently and considerable experience with the technique has afforded more confidence in its use in the latter half of this decade (see Jick H, Vessey MP: Case-control studies in the evaluation of drug-induced illnesses. Am J Epidemiol 1978; 107:1–7.).
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