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Pfizer contributes critical data to URMC drug safety initiative
Date:1/12/2009

Pfizer Inc. has agreed to provide the University of Rochester Medical Center (URMC) with a unique set of electrocardiographic data that will help researchers develop new methods to ensure the safety of experimental drugs. This is the first time a major pharmaceutical company has agreed to publicly share anonymous data from one of its drug safety trials, including data from the drug that was being evaluated.

Pfizer Global Research and Development's Sandwich Laboratory in the United Kingdom is releasing a large set of continuous electrocardiographic (ECG) recordings to URMC from which more than 1.5 million individual ECGs datasets can be extracted.

A full set of study data, which Pfizer is providing, is extremely valuable because it enables scientists to evaluate the electrical activity in the heart before and after study participants took the drug and compare that data to study subjects who received a placebo or a control drug that is known to prolong the repolarization process.

Earlier this year, URMC announced that it was collaborating with the U.S. Food and Drug Administration (FDA) to develop a national repository of data that will aid academic and industry researchers studying the electrical activity of the heart. The resulting database, called the Telemetric and Holter ECG Warehouse (THEW), consists of a digital catalogue of continuous recordings from both cardiac patients and healthy individuals and is available to academic researchers, pharmaceutical companies, contract research organizations, device manufacturers, and other interested parties.

The Pfizer data, in compliance with international privacy laws, has been fully anonymized, or stripped of any information that would enable individual patients to be identified. Additionally, the THEW was designed in order to comply with ethics and patient privacy laws; all data in the warehouse have been de-identified and the system is fully compliant with federal privac
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Contact: Mark Michaud
mark_michaud@urmc.rochester.edu
585-273-4790
University of Rochester Medical Center
Source:Eurekalert

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