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• W1573974893 abstract "Determining the causality of clinical events that are temporally associated with exposure to drugs and other medical products has long been one focus for those evaluating cases identified in clinical practice and reports collected in postmarketing drug surveillance in regulatory and product sponsor settings. It is also relevant to the clinical setting in developing a differential diagnosis to determine patient management. This chapter reviews most of the current methods, describes the core data elements needed for assessment that are common to most, and describes several perspectives on how the concepts of causality assessment have evolved over time. It also categorizes the approaches, from global introspection, to efforts to apply numerical scoring to the core data elements, and finally to application of more complex probabilistic (Bayesian) methods, and provides examples and identifies each method's strengths and weaknesses. It also describes the applications and regulatory requirements of importance to medical product regulators and manufacturers in some countries and separately identifies the role of causality assessment in medical publications of case reports. Finally, the different causality assessment approaches are considered in the context of future developments and how application of the methods can further the understanding of drug and other medical product effects." @default.
• W1573974893 created "2016-06-24" @default.
• W1573974893 creator A5057828829 @default.
• W1573974893 date "2012-01-03" @default.
• W1573974893 modified "2023-09-25" @default.
• W1573974893 title "Assessing Causality of Case Reports of Suspected Adverse Events" @default.
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• W1573974893 doi "https://doi.org/10.1002/9781119959946.ch33" @default.
• W1573974893 hasPublicationYear "2012" @default.
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