The form of statistical signal detection tested in this study can provide significant early warning in a large proportion of drug safety problems; however, it cannot detect all safety issues more quickly than other pharmacovigilance processes and hence it should be used in addition to, rather than as an alternative to, established methods.
Changes in the standard threshold for the count of drug-event combinations can result in a substantial improvement in efficiency of the signal detection process. Initially this change might be applied only to products with a well-established safety profile.
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