FDA, Lincoln Technologies to develop safety data mining technology

MAY 1–ROCKVILLE, Md.–The Food and Drug Administration (FDA) announced today the establishment of a Cooperative Research and Development Agreement (CRADA) with Lincoln Technologies, Inc. (Wellesley, Mass.)

According to the FDA, the purpose of this partnership is to use data mining¿a promising new technology¿to enhance FDA’s ability to monitor the safety of drugs, biologics and vaccines after they have been approved for use.

Data mining is a technique for extracting meaningful, organized information from large complex databases. The CRADA involves data that FDA already collects about adverse events involving approved drugs, biologics and vaccines. The specific data set used for data mining purposes does not include patient names, addresses, social security numbers or similar information.

Data collected from suspected drug-related adverse event reports and other electronic medical information could aid the FDA in identifying “signals” of adverse events and the patterns in which they occur. The more effective the tools FDA can use to detect such patterns, the faster it can act to evaluate and act on these reports as appropriate. For example, more effective data mining might allow the agency to identify a pattern of adverse events in a specific population of patients taking a drug, or in patients who take a certain combination of drugs, and the agency could then communicate this knowledge sooner to medical professionals and patients ¿ preventing more adverse events.

“Preventing adverse events associated with medical products is one of FDA’s top priorities,” said the Commissioner of Food and Drugs, Mark B. McClellan, M.D., Ph.D. “By making greater use of state-of-the-art statistical tools coupled with 21st-century medical information systems, we can act more quickly and effectively to prevent adverse events.”

FDA will continue to monitor the marketplace to ensure that products purporting to be dietary supplements are labeled properly and that claims being made for these types of products are not false or misleading.

The CRADA is expected to improve the utility of safety data mining technology. The FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) will work with Lincoln Technologies, Inc., to develop new and innovative ways for extracting information related to drug safety and risk assessment.

The CDER Principal Investigator for the CRADA, Paul J. Seligman, M.D., states that the “further development of this tool holds great promise as a way to optimize our evaluation resources and enhance our ability to identify drug-related safety concerns. Through the use of enhanced data mining techniques we hope to improve upon our current ability to identify adverse event patterns in post-market safety databases. Application of improved data mining tools has the potential for even earlier detection of safety signals associated with marketed products, especially adverse events from drug-drug interactions.”

The CBER Principal Investigator for the CRADA, M. Miles Braun M.D., adds that “this CRADA is intended to use modern computing and state-of-the-art statistical algorithms to sift through millions of suspected reaction reports and thousands of products to look for potential safety signals needing further scrutiny. The tools developed are expected to be highly useful aids to safety evaluators and reviewers.”

The agreement supports the FDA’s commitment to using the best science and the latest technology available to improve risk management of market products.


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