- Sentinel studies millions
Massive study plans to track 60,000,000 human patients
MedPageToday. 12 January 2011.
FDA 'Mini-Sentinel' System Up and Running.
By John Gever, Senior Editor, MedPage Today
The first phase of the FDA's ambitious Sentinel program for real-time monitoring of drug safety problems is now operational, allowing the agency to track events in 60 million Americans, officials said.
At a meeting in Washington and in a simultaneous online publication in the New England Journal of Medicine, program leaders drew back the curtain on Mini-Sentinel, a pilot program that accesses patient databases maintained by health plans and other organizations. The FDA contracted with the Harvard Pilgrim Health Care Institute in Boston and the Brookings Institution's Engelberg Center for Health Care Reform to design the system, which is now capable of querying claims data on some 60 million individuals, without revealing identities of specific patients.
In the NEJM article, representatives of the three organizations reviewed the development of Mini-Sentinel and plans for its future. Lead author of the paper was Rachel Behrman, MD, MPH, of the FDA. Other authors included former CMS Administrator and FDA Commissioner Mark McClellan, MD, PhD -- now at the Engelberg Center -- and Janet Woodcock, MD, current head of the FDA's drugs division.
Behrman and colleagues called the system "an early working model for secondary uses of data produced in the routine delivery of healthcare." The initiative was first announced in May 2008.
"The FDA will soon begin to actively monitor the data, seeking answers to specific questions about the performance of medical products, such as the frequency of myocardial infarction among
users of oral hypoglycemic agents," they wrote. Another immediate focus will be adverse events associated with common vaccines, Behrman and colleagues indicated.
"Using the Mini-Sentinel system, the FDA will also be able to obtain rapid responses to new questions about medical products and, eventually, to evaluate the health effects of its
regulatory actions," they wrote.
Key to the venture was the development of systems that allowed the basic data to remain in the participating health plans' computers. These organizations agreed to maintain the data in
a standard format, but they would retain control and protect individual patients' privacy.
When a request is sent from Mini-Sentinel, data from the individual systems are aggregated and made anonymous before they reach the FDA. "The initiative's distributed data network
allows each data partner to maintain physical and operational control over its own patient-level data, while providing the aggregated information needed to address the FDA's questions,"
according to Behrman and colleagues. "A typical result might include the number of new users of a product who experience a particular outcome, grouped according to age, sex, other treatments, and health status."
At this point, only insurance claims data are available in Mini-Sentinel, but Behrman and colleagues indicated that lab test results and vital signs recorded in electronic health records would be added. Farther out, data from device registries and state immunization records might be included.
Behrman and colleagues noted that the system could benefit agencies and organizations beyond the FDA, such as those concerned with quality measurement, public health surveillance, and comparative effectiveness.
"Healthcare data represent a precious resource that must be used to the fullest possible extent to promote the public health, while the rights of patients and consumers are protected," they argued.
Primary source: New England Journal of Medicine
Behrman R, et al "Developing the Sentinel System -- a national
resource for evidence development" N Engl J Med 2011;