Cardiovascular disease is the leading cause of death in the United States, accounting for over one quarter of all deaths every year. Some medical products intended to treat cardiovascular disease and other diseases have significant and potentially dangerous side effects related to their effects on the heart. Moreover, cardiac safety concerns are a leading cause for the recall of marketed drugs and abandonment of drug development programs for any indication. The Cardiac Safety Research Consortium (CSRC) was launched in 2006 through an FDA Critical Path Initiative Memorandum of Understanding with Duke University to support research into the evaluation of cardiac safety of medical products.

CSRC supports research by engaging stakeholders from industry, academia, and government to share data and expertise. Outputs of the CSRC include research projects taking advantage of waveforms released from the FDA ECG warehouse, Think Tank Incubator programs, and consensus white papers. Additional work is under way to expand the portfolio of research projects beyond the ECG data into other areas of cardiac safety evaluation from the preclinical through the postmarket periods.

The CSRC is excited about its past accomplishments and future directions. If you are interested in exploring current opportunities for involvement with the CSRC, please email us at cardiacsafety@dm.duke.edu.

We are excited to announce a new committee, the Partnership Liaison Committee. This committee provides a ‘single point of contact’ at the CSRC for partner organizations. View members.