Abstract
The study of causality of suspected adverse drug reactions (ADRs) forces us to look at our state of knowledge about drugs. Frequently, effects associated with a drug in the product label or literature are variably related to that drug and sometimes are only an expected event for the population exposed to the drug. Frequency and likelihood of causation are seldom known. Examples of this imperfect state of knowledge and the reasons for it are elaborated, citing the standard sources of information: clinical trials, spontaneous reports, and epidemiologic methods — cohort and case control studies. Each method generates data not amenable to standard statistical analysis. It is proposed that these data can be evaluated using Bayesian methods, which in turn would provide guidance for improved study design.
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