Timeliness of a Signal Detection Process as a Component of Effectiveness Assessment in a Drug Safety Department of a Large Pharmaceutical Company: Review Over a 5-Year Period.

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. Over this 5-year period, 568 (about 17%) of the 3481 signals submitted by the safety management team at the signal escalation boards were identified as new or changing signals. Of these 568 signals, 53 (10%) were detected first by health authorities (a quarter of which were class signals). In conclusion, the signal detection process at Novartis Pharmaceuticals could detect at least 9 of 10 signals prior to them being detected by health authorities.