By Deb Borfitz
April 6, 2009 | Drug Safety Alliance (DSA), one of the leading providers of safety services to the pharmaceutical industry, recently enlarged its capabilities to include the statistical horsepower of Phase Forward’s Empirica Signal. The data mining and signal detection software works off several million case reports of drug-related adverse events (AEs) contained in the FDA and World Health Organization databases which, when properly mined, can assist in identifying the disproportionate occurrence of AEs with specific product use.
Empirica Signal (formerly known as Web VDME) has until now been used primarily by the FDA and large companies with the financial wherewithal and in-house expertise to utilize the technology, says Elizabeth Garrard, DSA’s chief safety officer. Small and mid-tier companies have been more apt to rely on signal searches of their own proprietary databases by vendors like DSA. But they’re starting to drift to more statistically rigorous approaches of bigger companies in response to mounting pressure from the FDA to perform proactive risk evaluation and develop mitigation strategies for their drugs, ensuring benefits outweigh risks.
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| Elizabeth Garrard |
The “art” of signal detection is certainly enhanced with the use of Empirica Signal, says Garrard. The FDA database alone has close to four million AE case reports associated with all sorts of approved drugs, supplements, and over-the-counter remedies. That provides a sizeable background for the “disproportionality” analyses, as well as signal detection of one drug against all others in its class.DSA has sporadically used Empirica Signal over the past year, often after a troubling AE pattern was detected by Empirica Trace, a Phase Forward reporting tool that houses AEs in client-specific proprietary databases. But DSA now has “immediate access” to the more robust signal-detection software and its underlying databases via licensure with Phase Forward.
Garrard says DSA expects to see a return on its investment after a year. DSA is increasingly being approached by small and mid-size pharmaceutical companies that have come up against “emerging product risks” that might negatively impact product sales. But they lack comparison points with similar drugs to comprehensively evaluate their particular drug ahead of a costly FDA mandate based on the bad behavior of an entire class of compounds.
Empirica Signal is used solely in the post-marketing arena in which previously unseen and unexpected AEs start to emerge, says Garrard. “The FDA has said it’s no longer acceptable to be reactive. [Drug makers] need to look at risk in a more proactive, meaningful format.”
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| Doug Hill |
Other signal software tools use the same underlying algorithms to detect safety signals, says Doug Hill, DSA’s chief information officer. “Empirica Signal is one of the older, more established tools and is software that the FDA currently uses.” It also has several desirable add-ons, including a topic-tracking feature to document and track safety-related issues identified anywhere in the safety review process.Especially appealing to Garrard is that Empirica Signal provides a graphical at-a-glance drug profile overview of the product of interest. It also takes into account the possibility of confounding variables, such as use of multiple medications by a patient. Hill adds that “the power of Empirica Signal, combined with DSA’s proprietary signal detection reports, provides our clients comprehensive management of theoretical and real product risk.”
Phase Forward provides access to large segments of the source code for Empirica Trace, the AE reporting software, so users can configure and customize the software to their liking. “That’s an important attribute to a company like DSA that deals with multiple clients and business rules,” says Hill. These new products and their enhancements “keep DSA moving in the right direction, such as the ability to automatically create and send safety reports globally.”