Navigation Links
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 privacy (HIPPA) regulations.

"We are glad and thankful that Pfizer has chosen the THEW platform for sharing their data with the international scientific community'" said Jean-Philippe Couderc, Ph.D., director of the THEW initiative. "We believe the global strategy of our initiative, its legal framework, and the support received from the Food and Drug Administration have played key roles in the development of successful collaboration with companies like Pfizer."

The Pfizer data will be housed in THEW and will enable researchers to develop new tools to detect drugs that may have dangerous effects on the heart. The Pfizer data will consist of several important sets of ECGs from different phases of a study of a drug that did not reach the market because of its adverse effect of the process of cardiac ventricular repolarization the split-second period between the heart's contraction and recovery phase. If a drug prolongs the repolarization process, then it is generally believed to heighten the risk for adverse cardiac events, such as dangerous arrhythmias and heart attacks.

Sudden cardiac arrest is the leading cause of death in the United States, resulting in more than 450,000 deaths per year. Included in this number are deaths caused by drugs that trigger a predisposition to lethal cardiac arrhythmias or even the drugs themselves. As part of FDA's regulatory review process, the agency requires evidence of a drug's impact on the QT interval as one way to assess the cardiac risk associated with new compounds. The QT interval is a segment of an ECG recording that measures the process of ventricular repolarization. Prolongation of the QT interval associated with episodes of fatal ventricular arrhythmias is a leading cause of removal of drugs from the market and was a leading impetus toward international collaboration to develop specialized studies to monitor the QT prolongation effects of new drugs. The THEW project is part of this initiative.

The THEW database is a component of URMC's Heart Research Follow-up Program. The Program is an international leader in the science of heart arrhythmias and a rare genetic condition associated with an abnormal QT interval, called the congenital Long QT Syndrome (LQTS). URMC keeps an International Registry for LQTS, and follows thousands of families who have this inherited condition. One of the genetic forms of the QT prolongation syndrome is similar to the drug-induced syndrome, and the University's work focuses on developing the tools to identify individuals with either condition.


'/>"/>

Contact: Mark Michaud
mark_michaud@urmc.rochester.edu
585-273-4790
University of Rochester Medical Center
Source:Eurekalert

Related medicine news :

1. AUDIO from Medialink and Pfizer: November is National Epilepsy Awareness Month
2. Senator Gordon Smith Joins Virginia Garcia Memorial Health Center and Pfizer to Honor a Community Caregiver
3. CHASS Center, Inc. and Pfizer Honor Health Care Heroes
4. AUDIO from Medialink and Pfizer: Community Health Centers Celebrated for Making Quality Care Available to Uninsured Americans
5. New York-Based Sanders Law Firm Files Five Product Liability Lawsuits Against Pfizer on Behalf of Chantix™ Plaintiffs
6. Chantix Blamed for Suicide in Lawsuit Against Pfizer Filed by Cory Watson Crowder & DeGaris
7. Pfizer Launches Think Science Now
8. Pfizer to Pay $975,000 for Alleged Clean Air Violations at Connecticut Facility
9. Ranbaxy and Pfizer Settle Lipitor Litigation Worldwide
10. Novartis, Pfizer and Merck Take the Lead on Strong Relationships with Physicians, as Doctors Demand an Expanding Set of Services
11. Pfizers work on penicillin for World War II becomes a National Historic Chemical Landmark
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/25/2016)... ... June 25, 2016 , ... The temporary closing of Bruton Memorial Library on June 21 ... brings up a new, often overlooked aspect of head lice: the parasite’s ability to live ... not a common occurrence, but a necessary one in the event that lice have simply ...
(Date:6/25/2016)... ... ... As a lifelong Southern Californian, Dr. Omkar Marathe earned his Bachelors in ... School of Medicine at UCLA. He trained in Internal Medicine at Scripps Green Hospital ... at the UCLA-Olive View-Cedars Sinai program where he had the opportunity to train in ...
(Date:6/25/2016)... ... 2016 , ... Conventional wisdom preaches the benefits of moderation, whether it’s a ... the bar too high can result in disappointment, perhaps even self-loathing. However, those who ... , Research from PsychTests.com reveals that behind the tendency to set ...
(Date:6/24/2016)... ... June 24, 2016 , ... June 19, 2016 is World Sickle ... chronic pain and the benefits of holistic treatments, Serenity Recovery Center of ... Sickle Cell Disease. , Sickle Cell Disease (SCD) is a disorder of the red ...
(Date:6/24/2016)... ... , ... Global law firm Greenberg Traurig, P.A. announced that 20 Florida attorneys ... peers for this recognition are considered among the top 2 percent of lawyers practicing ... members of this year’s Legal Elite Hall of Fame: Miami Shareholders Mark D. ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... 24, 2016 Dehaier Medical Systems Ltd. (NASDAQ: ... develops, markets and sells medical devices and wearable sleep ... a strategic cooperation agreement with Hongyuan Supply Chain Management ... on June 20, 2016, to develop Dehaier,s new Internet ... agreement, Dehaier will leverage Hongyuan Supply Chain,s sales platform ...
(Date:6/24/2016)... Belgium , June 24, 2016 ... today announced the appointment of Dr. Edward ... as a Non-Executive Director, effective June 23, 2016.Dr. ... Compensation and Nominations and Governance Committees.  As a ... will provide independent expertise and strategic counsel to ...
(Date:6/23/2016)... June 23, 2016 Research and ... Excipients Market by Type (Organic Chemical (Sugar, Petrochemical, Glycerin), ... Topical, Coating, Parenteral) - Global Forecast to 2021" ... The global pharmaceutical excipients market is projected ... CAGR of 6.1% in the forecast period 2016 to ...
Breaking Medicine Technology: