FDA/Duke Clinical Research Institute join forces

October 2, 2006

The Duke Clinical Research Institute in conjunction with the FDA will create a virtual electronic database of more than 200,000 electrocardiograms (ECGs) in order to identify as early as possible the potential effects that drugs and devices may have on the heart.

The Duke Clinical Research Institute in conjunction with the FDA will create a virtual electronic database of more than 200,000 electrocardiograms (ECGs) in order to identify as early as possible the potential effects that drugs and devices may have on the heart. The idea is to recognize biological measures that will help predict which patients are at an increased risk for cardiovascular side effects. Janet Woodcock, M.D., deputy commissioner for operations at the FDA, said that for decades the FDA received no quality copies of ECGs on paper. Woodcock said that limited the agency's ability to understand why some treatments affected a patient's heart. "This initiative should ultimately lead to the development of safer and more effective treatment."

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