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FDA NEWS RELEASE

FOR IMMEDIATE RELEASE
P06-147
September 27, 2006

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FDA and Duke Clinical Research Institute Form Partnership to Collaborate on Cardiac Safety Virtual
'Warehouse' of Electrocardiograms Will Serve as Primary Tool In Cutting-Edge Safety Research

The U.S. Food and Drug Administration (FDA) today announced a partnership, under the agency's Critical Path Initiative, with Duke Clinical Research Institute (DCRI) to develop a new generation of tools to identify, as early as possible, the potential effects that drugs and devices may have on the heart -- one of the more ominous side effects associated with such products.

The research will be conducted using a virtual electronic database of more than 200,000 electrocardiograms (ECGs) amassed by the agency from the clinical trial data submitted as part of new drug applications.

"For years we have received generally low-quality copies of ECGs on paper, and we were limited in our ability to use the information to understand why some treatments affected a patient's heart," said Andrew C. von Eschenbach, M.D., Acting Commissioner of Food and Drugs. "Through the development of digital ECG data standards in 2004, the development of the ECG warehouse in 2005, and this partnership in 2006, we hope to identify patterns that will help to predict which patients are at an increased risk for cardiovascular side effects. This knowledge can guide the development of safer treatments."

FDA and the Duke Clinical Research Institute are developing a consortium with members of academia, patient advocacy groups, other government and non-profit organizations and industry to coordinate and support a variety of research projects involving ECGs obtained in clinical trials. Through the consortium, FDA and DCRI will identify gaps in cardiac biomarkers and prioritize projects based on those needs.

Research shows that women are at higher risk of arrhythmias (abnormal heart beats), but it is not known whether this difference in susceptibility is related to different responses to drugs. Among the first applied projects the consortium will address is a review of gender differences in the effects of drugs on the ECG. A second research project will evaluate the four current methods of measuring ECGs and develop criteria to determine the best method to be used in a particular research study.

"By selecting the most appropriate method for measuring ECGs, we can better assess the impact of a drug or device on patients," said Norman Stockbridge, M.D., Director for CDER's Division of Cardio-Renal Drug Products.

Under the framework of this consortium, Duke and FDA researchers, together with other industry and academic consortium partners, will use the database to identify early indicators for potentially life-threatening cardiac arrhythmias. Strategies will range from the systematic comparison of variants of existing risk-evaluation techniques (to select the most efficient methods) to searching for novel ECG waveform features capable of detecting small adverse drug effects.

"Through its academic mission, the DCRI is committed to identifying and developing more accurate measures of cardiac safety. We will continue to advance the science supporting safety in drug development," said Dr. Robert Califf, Director of DCRI / Vice Chancellor for Clinical Research of the Duke University Medical Center. "This goal is shared with the FDA, and we are proud to be an integral member during the process that will bring a priority area of the Critical Path Initiative from concept to reality."

In October 2005, FDA and the Duke Clinical Research Institute co-sponsored the first in a series of meetings on improving the evaluation of cardiac safety during product development, a high priority under FDA's Critical Path Initiative. The Cardiac Safety and Critical Path Initiative Think Tank brought together representatives of academic research institutions, industry, professional societies, patient advocacy groups, and government agencies as part of a long-term effort to foster the development of tools needed to improve cardiac safety. Another meeting of the group is scheduled for November 3, 2006 at Duke University.

The ECG Warehouse

Following the establishment of an ECG waveform and annotation standard, the FDA partnered with Mortara Instrument Inc., to develop a digital ECG warehouse to support the storage and review of the submitted data. Under the terms and conditions of a Cooperative Research and Development Agreement (CRADA), the FDA's ECG Warehouse was designed and built and contains ECGs submitted as part of submissions to the agency, separated from any personal patient information.

The data standards that enabled this step were a product of Clinical Data Interchange Standards Consortium (CDISC) and Health Level 7 (HL-7), organizations in which FDA and industry are cooperating to develop a comprehensive set of standards for clinical trial data. Through such efforts, the agency expects to enable other similar research opportunities across the full range of data collected in clinical trials of new drugs. Proprietary and nonpublic information will only be disclosed in accordance with FDA regulations and appropriate confidentiality agreements.

The Critical Path Initiative

The Critical Path Initiative is the FDA's premier initiative to modernize the drug development process. Modernizing the medical product development sciences will create new opportunities to improve product safety by strengthening our postmarketing surveillance of adverse events and utilizing new areas of science (genomics, proteomics, and related disciplines, as well as bioinformatics) to improve scientific understanding and prevention of safety problems. The agency has entered into a number of partnerships to develop tools that will enhance our efforts in improving drug safety.

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