FDA TO RESEARCH CARDIOVASCULAR BIOMARKERS

The FDA will be working with Duke University's Clinical Research Institute to develop biomarkers identifying potential cardiac side effects from certain drugs and devices.

The FDA will use an electronic database of more than 200,000 electrocardiograms (ECGs) to identify biomarkers that will predict which patients are at an increased risk for cardiovascular side effects, the agency announced Sept. 27. The FDA and Duke will also develop a consortium with academics, patient advocacy groups, government agencies, industry and nonprofits to help assess this data. Biomarkers are indicators of normal biological processes that show how well a particular treatment will work.

This data will "ultimately lead to the development of safer and more effective treatments," Andrew von Eschenbach, the acting agency commissioner, said in a release. Janet Woodcock, deputy commissioner for operations, added that the effort will "help build safety into products in a more predictable way." The agency originally announced this partnership as part of its response to a recent Institute of Medicine report on drug safety.

These studies could change the way the agency assesses clinical trials, Woodcock said. The agency will study how large trials need to be to assess cardiac events and may develop guidance on how to do clinical trials on cardiac abnormalities caused by a drug, she added.