Designing Spontaneous Signalling Programs

In order to generate fully formed signalling arguments on a timely, ongoing basis, one or more AE signalling methods must be deployed in a logical design that facilitates the refinement of collections of raw reports into finished spontaneous signals. To accomplish this, report-based procedures, which are amenable to automation, are first used to create a list of "interesting" product-AE pairs (Finney, 1965, 1974; DuMou-chel, 1999). Then, case-based procedures, which are time intensive and epidemiologic in orientation, are used to refine these suggestions into full-fledged arguments. This sequence corresponds roughly to the concepts of "hypothesis generating'' and ''hypothesis strengthening" that have been invoked to explain signalling methodology (Meyboom et al., 1997a). In establishing spontaneous signalling programs, it makes sense for the evaluator to select signalling methods that can meet monitoring program requirements, including: (1) type of spontaneous reporting system providing the report data; (2) appropriateness of particular data strategies; (3) applicability of the proposed methods to the monitored product and its use; and (4) complementarity and non-duplication of function among methods selected for the program.

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