FDA to upgrade its data-mining skills and 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 data-mining techniques for the Adverse Events Reporting System.

The Oracle9i database already stores more than 2 million reports of patients' bad reactions to drugs and biologics, and more than 300,000 new reports arrive each year, said Paul J. Seligman, director of the Office of Pharmacoepidemiology and Statistical Science in FDA's Center for Drug Evaluation and Research.

FDA doesn't know how many prescriptions have been written for a given medication or its sales distribution lag time.

That makes it difficult to tell whether a given number of headaches'or heart attacks'is a significant side effect. FDA needs better data-mining tools to spot trends and drug interactions, Seligman said.

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