DURHAM, NC – Scientists will soon have a new resource to help them develop tools to more quickly spot potential safety problems while developing new drugs.

The tool is a massive repository of digital electrocardiogram (ECG) waveforms systematically organized like an electronic library to support a wide array of research efforts defining key aspects of heart safety.

The repository or ECG “warehouse” is being created by the Cardiac Safety Research Consortium (CSRC), a public-private partnership formed through a Memorandum of Understanding between the Food and Drug Administration and the Duke Clinical Research Institute in 2006.

The warehouse will first be populated by ECGs from studies contributed by Merck, GlaxoSmithKline and Eli Lilly.

Mitchell Krucoff, M.D., a cardiologist at Duke and co-director of the CSRC, points out that cardiac safety is an important aspect of all pharmaceuticals.

Why ECG saftey studies are required
Many drugs, including some not necessarily intended for heart care, such as antibiotics, pain relievers and anti-depressants may have properties that could alter the electrical rhythm of the heart, creating the potential for life-threatening arrhythmias.

Krucoff says that is why ECG-based safety studies are required for regulatory approval of most new drugs.

But he adds that current cardiac safety studies are generally expensive, time-consuming and limited in the safety information they produce.

“The CSRC ECG warehouse will make it much easier to access and compare large numbers of ECGs from patients exposed to drugs with known safety concerns.

In assessing safety, we look for changes in ECG waveform shape or duration because they can yield important clues about potential side effects such as life-threatening arrhythmias,” says Krucoff.

Having large numbers of records in one place will enable researchers to improve or develop tools that identify worrisome ECG changes more accurately and efficiently.

Pharmaceutical companies have been submitting millions of ECG waveforms for FDA scrutiny, but until now, those data have been confidential because they contain proprietary information about specific drugs under review.

Pharmas donated millions
In collaboration with leaders in the Center for Drug Evaluation, the Center for Devices and Radiological Health, the Office of Women’s Health, and the Office of the Commissioner at FDA, we have developed a process through which pharmaceutical companies and the FDA can agree to de-identify ECG safety studies and release them to the CSRC.