Sept. 13, 2007 | CLÆRITY is not a misspelling. It is the name of the latest pharmacovigilance product offered by ProSanos, a provider of safety and risk management services. CLÆRITY, launched at the DIA annual meeting in June, is a Web-based application designed to improve how adverse events, or “AEs,” are mined, analyzed, and interpreted. As ProSanos president and CEO Jonathan Morris explains, the product uses the company’s core data-mining technology to detect potential drug safety signals. CLÆRITY runs on top of the FDA’s Adverse Event Reporting System (AERS), a massive database that supports FDA’s post-marketing safety surveillance program for all approved drugs and therapeutic biologic products in the U.S.
At DIA, ProSanos’ vice president research, Alan Hochberg, presented the first head-to-head study showing that CLÆRITY detected 45 percent more drug safety signals than a leading competitor. “FDA is very interested in the product, and presently, we are undergoing the contracting process with the agency,” said Morris. “The big differentiators for our product are higher sensitivity to signals than what’s being used today, better performance, an easy-to-use graphical interface, and results in seconds, not minutes or hours.”
The AERS database contains almost 2 million of records, known as spontaneous reports, submitted by biopharmaceutical companies, healthcare providers, consumers, and lawyers. Although anyone can download the information from the FDA website, FDA does not provide tools to analyze or interpret the data. According to Morris, several companies offer first-generation tools for data mining, useful mostly for statisticians and data mining experts. CLÆRITY, a second-generation application, enables a much wider range of users to access, search, and interpret this vast collection of data.
“There are more than a dozen dimensions that someone can use to help determine if there is a safety signal for a particular drug,” says Moarris. “There is information about the drug such as class effect, age effect, and gender effect.” The product also detects signals hidden within the background rate of common medical conditions, such as myocardial infarction, stroke, and seizure. Investigations are interactive and yield two-dimensional visual presentations of potential safety signals, unlike first-generation products that typically provide a one-dimensional list or table and work in batch mode.
The visualizations are enabled by PVmaps, a patent-pending data-mining algorithm that underlies CLÆRITY as well as the company’s safety and risk management services. PVmaps, a .NET Web-hosted application, detects drug/event combinations occurring at higher-than-expected frequencies in clinical data. It maps out answers to pharmacovigilance questions such as: What are the significant signals for a drug of interest? Has a safety signal become more significant over time? How does the drug’s safety profile compare to another drug indicated for the same condition?
As Morris sees it, CLÆRITY represents the next generation of data mining and safety tools. “The system works as fast as the user thinks, so instead of waiting for results, their time is now spent interpreting and asking more questions.”
Morris says product acceptance has been strong, and among pharmaceutical companies who perform data mining in drug safety, there is an awareness of the gaps in the existing technology and an acknowledgement that this technology advances the field.
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