Agreement between the Food and Drug Administration and the THEW
FDA and University of Rochester signed a collaborative agreement.
On June 23rd, 2011, the partnership between the FDA and the THEW has been renewed after a successful first three years of collaboration. This second agreement has been signed by Dr. Janet Woodcock (Director of the Center for Drug Evaluation and Research, FDA). A copy of this agreement is available in PDF format here .
The former agreement was signed on May 27th 2008. This first Letter of Agreement with University of Rochester (UR) for the Telemetric and Holter ECG Warehouse Initiative was a 3-year agreement accompanied by a fully executed confidentiality disclosure agreement.
This UR-FDA partnership aims at promoting cross-fertilization of scientific knowledge, resources and ideas that will advance the field of quantitative electrocardiography, the THEW will strive to:
Develop specific projects to implement and to grow the repository of ECG information in the THEW;
Facilitate scientific projects toward the development, testing and validation of ECG-related technologies and platforms;
Leverage expertise and resources toward the implementation of collaborative projects among FDA, UR, and other public and private stakeholders;
Identify, develop and evaluate new electrocardiographic markers of cardiovascular risk related to management of patient care and evaluation of new molecular entities;
As appropriate, incorporate scientific findings from the THEW into the premarket evaluation process for electrocardiographic devices and associated methodologies, and into the total product life cycle.
The U.S. Food and Drug Administration is interested in the development of improved technologies to evaluate drug safety and efficacy. This interest has been officially expressed in the Critical Path Initiative which is the Agency's attempt "to stimulate and facilitate a national effort to modernize the scientific process through which a potential human drug, biological product, or medical device is transformed from a discovery or a "proof of concept" into a medical product". In the field of drug safety, one approach is to assess the cardiac safety of a new compound by investigating its delaying effect on the QT interval from the surface electrocardiogram (ECG). Today drug-induced QT prolongation is used as a surrogate marker of drug cardiotoxicity, yet the scientific community has strongly questioned its validity and there is a consensus on the need for novel technologies that would improve the current safety guidelines.