Background

On 27 September 2006, the U.S. Food and Drug Administration (FDA) announced a partnership, under the agency’s Critical Path Initiative, with Duke University (Duke) to develop a public-private partnership focusing on cardiac safety, and new medicinal product development. Duke’s Duke Clinical Research Institute (DCRI) manages this Cardiac Safety Research Consortium, which involves industry, academics, and regulators. The FDA believes that this is an important effort and has involved senior representatives from the FDA Commissioner’s Office, Center for Drug Evaluation and Research, Center for Devices and Radiological Health, and the Office of Women’s Health.

Under the Memorandum of Understanding (MOU), signed between the FDA and Duke, the initial specific areas of scientific activities include, but are not limited to, the following:

1. Creating an ECG library from clinical trials that could be used for identifying early predictors of cardiac risk (Cardiac Risk ECG Library);
2. Utilizing the Cardiac Risk ECG Library to qualify new ECG biomarkers of cardiac risk;
3. Utilizing the Cardiac Risk ECG Library to create a set of ECG reference standards;
4. Developing additional research and regulatory evaluation tools to facilitate clinical decision-making and future medical product development in the interest of public health; and
5. Developing nomenclature and tools to facilitate the development of standards that will provide the evidence base for new diagnostics and assessment tools, and to develop educational tools to make these research results widely available to researchers, clinicians and patients.

Initial projects are intended to serve as models for future projects, as well as provide critical scientific data for the detailed understanding of cardiac safety for new medical products. It is expected that these results will be used by both regulators and industry to maximize the understanding of cardiac safety and to inform future guidance documents. Although the results of these projects will remain in the public domain, industry will be free to incorporate these findings into their research and development efforts.

To date, Duke has obtained financial support from 20 organizations for the CSRC to support the initiation of this consortium. Funds are used to develop research infrastructure as well as to conduct the initial proof of concept projects.