Office of Drug Safety to Use Data Mining to Analyze AERS

FDA drug safety reviewers should have a new data-mining tool this spring to help them evaluate the hundreds of thousands of reports submitted annually to the Adverse Events Reporting System (AERS) -- a system that is now more widely available to the public online.

The FDA has been working for almost two years through a cooperative agreement to implement a desktop data-mining software system, which should be ready by March, said Min Chen, associate director of the FDA's Division of Drug Risk Evaluation in the Office of Drug Safety.

Data mining is very popular in the private sector, but hasn't been used extensively by the FDA, Chen told a Drug Information Agency conference in Washington, D.C. She noted that once the FDA's data-mining system is operational, the tool will not replace other traditional methods of evaluating data, Chen said.

She also noted that the agency is still trying to improve the AERS database to ensure that results from any data-mining software program are consistent, reliable and stable. This data-mining program will be based on AERS, which has seen a significant growth in the number of reports annually, to roughly 350,000 last year.