Large health care databases are used extensively for pharmacoepidemiologic studies.
Unique methodological issues arise when applying self-controlled designs (ie, using within …

Purpose To assess case‐only designs for surveillance with administrative databases.
Methods We reviewed literature on two designs that are observational analogs to crossover …

Characterization of relationships between time-varying drug exposures and adverse events
(AEs) related to health outcomes represents the primary objective in postmarketing drug …

Purpose Consensus is needed on conceptual foundations, terminology and relationships
among the various self‐controlled “trigger” study designs that control for time‐invariant …

In 2007, the US Congress passed the Food and Drug Administration (FDA) Amendment Act,
1 which called for the establishment of an “active postmarket risk identification and analysis …

Most approaches used in postmarketing drug safety monitoring, including spontaneous
reporting and statistical risk identification using electronic health care records, are primarily …

Background: Self-controlled designs, both case–crossover and self-controlled case series,
are well suited for evaluating outcomes of drug–drug interactions in electronic healthcare …

Background Despite the frequent use of self-controlled methods in
pharmacoepidemiological studies, the factors that may bias the estimates from these …

Active medical product monitoring systems, such as the Sentinel System, will utilize
electronic healthcare data captured during routine health care. Safety signals that arise from …

We introduce a new sequential monitoring approach to facilitate the use of observational
electronic healthcare utilization databases in comparative drug safety surveillance studies …