Systematic clinical data mining can accelerate the speed at which adverse event ‘‘signals’’ can be detected. Such an active national surveillance system would allow drugs to be monitored longitudinally over their entire life cycle, providing
the FDA with timely access to new information with which to evaluate a drug’s risk profile. We have reached a critical junction in drug discovery and safety monitoring.
Technology and methods now exist to vastly improve our ability to better elucidate the risk-benefit of pharmaceuticals,and thus better inform both clinicians and patients in treatment
decisions. Now is the time to implement these processes
to avoid future instances in which large numbers of
patients suffer needlessly from previously undetected safety
signals.