New Safety Surveillance System to Shape R&D - Applied Clinical Trials

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New Safety Surveillance System to Shape R&D Broader access to health care data has potential to alter pre- and postmarketing clinical studies.

Source: Applied Clinical Trials



Jill Wechsler
The Food and Drug Administration is launching the Sentinel Initiative to expand and improve medical product risk identification and evaluation. The FDA Amendments Act (FDAAA) requires the agency to establish an "active postmarket safety surveillance and analysis" system that will provide safety data on 25 million patients by 2010 and 100 million by 2012. Instead of relying on passive, unreliable adverse event reports sent to FDA by doctors and pharmacists, the agency seeks to detect safety signals much more quickly through links to extensive health information databases.

This Sentinel System also will encourage more adverse event reporting by health professionals, more effective analysis of health information, and better methods for communicating safety information to providers and patients. "We may be entering a new era for determining how drugs should be used on the market," commented Mark McClellan, former FDA commissioner and Medicare chief, who is now at the Brookings Institution where he chaired a forum on postmarket evidence.

Spurring discovery

Improved understanding of how drugs affect patients in real world settings also has potential to inform drug discovery and reshape biomedical research and drug development. FDA Commissioner Andrew von Eschenbach described this initiative as an opportunity to use the delivery of health care as a discovery platform. Similarly, Johnson & Johnson Corporate Vice President Garry Neil predicted a "revolution in the entire health care system"; bringing information on how drugs affect people back to discovery will support new medical products that are more effective, safer, and less costly.

McClellan explained further at the June annual meeting of the Drug Information Association (DIA) that an active postmarket surveillance system fits a life-cycle approach to drug development and regulation, moving away from distinct pre- and postmarket regulatory processes. FDA concerns about drug safety are "not just a pendulum swing," he commented, but reflect higher public expectations about drug safety over the long run.

A more efficient and proactive postmarket surveillance system also offers support for FDA approval of new drug applications (NDAs). If the regulators have confidence that safety problems will be identified quickly and appropriately after a drug goes to market, they may be more willing to approve an application for a product that raises safety concerns. The hope of advocates for the Sentinel System is that it will give the public and FDA reviewers more confidence about approving innovative and targeted medical products.

FDA officials, moreover, are optimistic that the Sentinel System may reduce the size and scope of late stage clinical trials and of postapproval studies. Phase III trials are large and costly because they address drug safety issues, McClellan pointed out. But a more robust system for monitoring how drugs are used by patients, he explained, "takes off some of the pressure on Phase III studies to address all the safety issues before a drug comes to market." Although sponsors fear that earlier and broader assessment of postmarket data will yield false negatives that set off alarms on every new drug, Jesse Goodman, director of the Center for Biologics Evaluation and Research (CBER), suggested that such oversight may put to rest concerns about the safety of a new drug or vaccine that are raised in prelicensure studies. "The data can cut both ways," he observed at a press briefing.

More efficient postmarket surveillance also may reduce FDA demands for extensive Phase IV studies, as health system information becomes more effective in identifying safety issues. Instead of requiring manufacturers to sponsor a long list of postmarket clinical studies, FDA reviewers may call for six months or a year of database monitoring for certain anticipated safety concerns.


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