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 …

Medical product post-market safety surveillance can be conceptually framed as a three-
stage process of signal generation, signal refinement, and signal evaluation. Signal …

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

Active drug safety monitoring based on longitudinal electronic healthcare databases (a
Sentinel System), as outlined in recent FDA‐commissioned reports, consists of several …

ABSTRACT The US Food and Drug Administration (FDA)'s Mini‐Sentinel pilot has created a
distributed data system with over 125 million lives and nearly 350 million person‐years of …

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

Background Observational healthcare data offer the potential to enable identification of risks
of medical products, but appropriate methodology has not yet been defined. The self …

Purpose Ensuring that drugs have an acceptable safety profile and are used safely is a
major public health priority. The Centers for Education and Research on Therapeutics …

After half a century of monitoring voluntary reports of medical product adverse events, the
Food and Drug Administration (FDA) has launched a long-term project to build an adverse …

Spontaneous reporting systems (SRS) as a form of post-market drug-safety passive
surveillance were created several decades ago. SRS do have several limitations. Somewhat …