FDA, Duke Examine Cardiac Drug Safety


October 2, 2006

FDA and Duke Clinical Research Institute will be working to develop a new generation of tools that enable early identification of potential cardiac side effects of drugs and devices. The agency will use a database comprising more than 200,000 ECGs to conduct the research.

FDA acting commissioner Dr Andrew C. von Eschenbach says the combination of database warehouse and the Duke partnership are allowing researchers identify biological measures that will help to predict which patients are at an increased risk for cardiovascular side effects.

“This will ultimately lead to the development of safer and more effective treatments," he stated in an FDA media release.

The first project to be undertaken will be a review of gender differences in the effects of drugs on the ECG. A second research project will evaluate the four current methods of measuring ECGs and develop criteria to determine the best method to be used in a particular study.