Refining Data Mining: Taking Control of a Powerful New Tool
This article was originally published in RPM Report
Executive Summary
FDA is about to get more money and new technology to upgrade its drug safety systems. One new technique likely to emerge in a big way is "data mining"-automated safety signal detection. The question is: who will mind the data miners?
You may also be interested in...
Bristol-Myers Squibb/AstraZeneca Onglyza is Guinea Pig for FDA Mini-Sentinel Post-Market Surveillance
FDA’s Congressionally-mandated active surveillance system, Sentinel, is ready for shakedown cruises in 2011. One of the first projects will be a close examination of real-world experience and cardiovascular events associated with saxagliptin. That’s a dubious distinction for BMS/AZ, the co-marketers of Onglyza–but it also sets up a new dynamic that all sponsors should watch.
Bristol-Myers Squibb/AstraZeneca Onglyza is Guinea Pig for FDA Mini-Sentinel Post-Market Surveillance
FDA’s Congressionally-mandated active surveillance system, Sentinel, is ready for shakedown cruises in 2011. One of the first projects will be a close examination of real-world experience and cardiovascular events associated with saxagliptin. That’s a dubious distinction for BMS/AZ, the co-marketers of Onglyza–but it also sets up a new dynamic that all sponsors should watch.
Surveying the Landscape for Active Surveillance
The transition away from spontaneous adverse event reporting systems to real-time active surveillance is under way, but far from complete. Alan Goldhammer, the former head of regulatory affairs at the Pharmaceutical Research & Manufacturers of America trade association, surveys the landscape of active surveillance activities.