New research center to focus on cardiac safety and ...(rrent methods can be improved. Las...),Health

Last year, the FDA partnered with the University of Rochester to create an electronic database of ECG data to help foster research in this field. The Telemetric Holter Electrocardiograph Warehouse (THEW) which now forms the core of the new Center consists of thousands of recordings from individuals with cardiac arrhythmias, healthy volunteers, individuals with drug induced cardiac events, individuals participating in clinical trials, and rare cardiac events. This data comes from individuals who have worn cardiac monitoring devices to record their heart activity, usually for hours or days at a time.

This data will be provided to academic and private research organizations to help them design and validate new tools and methods to detect abnormal cardiac activity. They Center will also serve as a bridge between researchers and federal regulators to help facilitate the development of new technologies that can improve safety and reliability of information from clinical trials.

"The Center represents probably the first opportunity in the history of cardiac safety where data of this scale and value has been gathered together and made available to academic and industry researchers," said Couderc. "At the same time, these resources will help support a scientific network in which ideas and concept related to ECG technologies can be discussed and implemented with the input from representatives from the National Institutes of Health and the FDA."

The Center is an outgrowth of the University of Rochester's Heart Research Follow-Up Program which has been a leader in the science of heart arrhythmias for over 20 years. The program maintains an international registry of individuals with a rare inherited syndrome that is similar to drug induced cardiac events.

To date, the project has received ECG data from pharmaceutical companies Pfizer and Roche and Munich University in Germany. Academic rese
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