FDA seeks data-mining tools

FDA seeks data-mining tools

The Food and Drug Administration has signed a two-year cooperative R&D agreement with Lincoln Technologies Inc. of Wellesley Hills, Mass., to develop new data-mining techniques for the agency's Adverse Events Reporting System.

The adverse-events database already contains more than 2 million reports of patients' reactions to drugs and biologics. More than 300,000 new reports are added annually, said Paul J. Seligman, director of the Office of Pharmacoepidemiology and Statistical Science in FDA's Center for Drug Evaluation and Research.

Biologics are therapeutic substances derived from living sources such as human blood plasma, animals and microorganisms.

'It's basically our window into what is happening with drugs once they're marketed in the United States,' Seligman said.

FDA investigators need the data-mining tools to spot trends in the data and to study complex drug interactions.
The adverse-events system, using an Oracle Corp. database, stores ages and genders of patients but not their names or other identifying data, Seligman said.

He is one of two principal FDA investigators for the research agreement, which also involves the agency's Center for Biologics Evaluation and Research.

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