The effectiveness of a signal detection process integrating traditional and data-mining techniques was evaluated retrospectively in the real-world setting of a drug safety department at a large pharmaceutical company. To this effect, annual metrics on all signals detected internally or externally for all approved Novartis drugs were reviewed from January 1, 2007, to December 31, 2011. Timeliness (ie, the ability of the signal detection process to detect signals prior to any regulator) was taken as a main component of effectiveness.
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