Navigation Links
Pfizer Contributes Critical Data to URMC Drug Safety Initiative
Date:1/12/2009

ROCHESTER, N.Y., Jan. 12 /PRNewswire-USNewswire/ -- 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.

THEW website: http://www.thew-project.org/

About the University of Rochester Medical Center

One of the nation's top academic medical centers, the University of Rochester Medical Center (http://www.urmc.rochester.edu) forms the centerpiece of the University's health research, teaching, patient care, and community outreach missions. The Medical Center receives more than $230 million in external research funding per year and the University of Rochester School of Medicine and Dentistry ranks in the top one-quarter of U.S. medical centers in federal research funding. The University's health care delivery network is anchored by Strong Memorial Hospital - a 739-bed, University-owned teaching hospital. As upstate New York's premier health care delivery network, patients benefit from the Medical Center's robust teaching and biomedical research programs.


'/>"/>
SOURCE University of Rochester Medical Center
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Medarex Receives Milestone Payment from Pfizer for Investigational New Drug Application Filing
2. Silence Therapeutics to Receive $1.9m Milestone Payment as Pfizer and Quark Commence Phase II Trial
3. Quark Pharmaceuticals Announces First Patient Dosing by Pfizer in Phase II Trial of RNAi Therapy in Diabetic Macular Edema
4. MannKind Addresses Pfizers Announcement Regarding Exubera
5. Tacere Therapeutics Enters Collaboration and License Agreement With Pfizer To Develop and Commercialize RNAi Hepatitis C Drug
6. NicOx Announces Pfizer Initiates Phase 2 Clinical Development for PF-03187207 in Japan
7. Rigel Announces Initiation of Phase 1 Clinical Trial of R343 for Allergic Asthma by its Partner Pfizer
8. Coley Pharmaceutical Group and Pfizer Nominate Additional Anti-Cancer Compound for Clinical Development
9. Kosans Motilin Receptor Agonist, Licensed to Pfizer, Enters Phase 1 Clinical Trial in Gastroesophageal Reflux Disease
10. Wyeths Torisel and Roche/Genentechs Avastin Will Challenge Pfizers Sutent to Become the Clinical Gold Standard for Treatment of Metastatic Renal Cell Carcinoma
11. Critical Pharmaceuticals Enter Sustained Release hGH Arena
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/24/2016)...   , Study met ... bowel cleansing and superiority in , ... of the ascending colon   ... Norgine B.V. today announced new positive data from the phase ... preparation) versus standard 2 litre PEG with ascorbate. The study met ...
(Date:5/24/2016)... May 24, 2016  NxStage Medical, Inc. (Nasdaq: ... on advancing renal care, today announced that Jeffrey ... in the following schedule of investor conferences. Where applicable, ... at http://ir.nxstage.com/ .   ... Conference NY, NY           Friday, June 10, 2016 1:30 ...
(Date:5/24/2016)... HONG KONG , May 24, 2016 ... , the world , s ... and AV fistula intervention   OrbusNeich, a ... solutions, has expanded its portfolio to include products to ... balloons are the company,s first entry devices for lower ...
Breaking Medicine Technology:
(Date:5/27/2016)... ... 27, 2016 , ... More than a third of American adults are considered ... surgery has received increased attention in recent years, as an article published ... weight loss, most people are familiar with the basic requirements of maintaining a healthy ...
(Date:5/27/2016)... York, NY (PRWEB) , ... May 27, 2016 , ... ... campaign returns for a third time to shed lights on the variety of topics ... and inspirational stories, “Nurse Appreciation” tackles why this career has gone from being in ...
(Date:5/27/2016)... ... May 27, 2016 , ... In ... the many who are unaware of the plight of aphasia. In collaboration with ... the “Stroke Awareness” campaign. , The link between stroke and aphasia is relatively ...
(Date:5/27/2016)... (PRWEB) , ... May 27, 2016 , ... ... in scholarships to students studying complementary medicine. Allison Outerbridge is this year’s ... her award on May 18 at the university’s Student Leadership Awards ceremony. , ...
(Date:5/26/2016)... , ... May 26, 2016 , ... W.S. Badger ... has been honored with a 2016 When Work Works Award for its use of ... of the national When Work Works project administered by the Families and Work Institute ...
Breaking Medicine News(10 mins):