Rochester researchers join federal initiative to improve drug safety

The University of Rochester Medical Center will participate in a unique research partnership with the National Institutes of Health and the U.S. Food and Drug Administration (FDA) to develop new methods to assess the safety of drugs in clinical trials with greater speed and certainty.

The research, to be directed by Rochester researcher Jean-Philippe Couderc, Ph.D., will, for the first time, give scientists access to a huge FDA database of electrocardiograms (ECG) for the purpose of identifying early predictors of cardiac risk. This project is part of the "Critical Path" initiative launched two years ago by the FDA to accelerate the process of bringing medical breakthroughs to patients while at the same time ensuring safety and reducing drug development costs.

"Cardiac toxicity is a major issue for the pharmaceutical industry," said Couderc. "In recent years, many drugs have been pulled from the market because of concerns that they may cause adverse cardiac events. And this is not just limited to cardiac drugs; it also includes antibiotics, anti-psychotic, heartburn, and anti-histaminic drugs among others."

The most common form of this toxicity manifests itself in a drug's impact on cardiac repolarization a split-second period between the heart's contraction and recovery phase. A drug-induced prolongation of this period, called the QT interval prolongation, can significantly increase risk for developing fatal arrhythmias and sudden cardiac death.

Beginning last year, the FDA required companies to submit ECG data from clinical trials in electronic form. The result has been the creation of a large 500,000 and growing electronic warehouse of ECGs. Couderc and his team will be the first outside researchers to gain access to this database.

Of particular interest to Couderc is a specific set of control data. The FDA requires drug companies to include ECGs from subjects who have been administered the drug moxifloxacin, a

Contact: Mark Michaud
University of Rochester Medical Center

Page: 1 2 3

Related medicine news :

1. Rochester spreads knowledge of cancer-related fatigue
2. Rochester study rolls out RU-486 to treat uterine fibroids
3. University of Rochester spin-off secures $2 million in funding
4. Rochester study shows ethnic disparities in medicare claims
5. Rochester launches Cancer Stem Cell Research Program
6. Stanford researchers find culprit in aging muscles that heal poorly
7. UCLA researchers awarded $9M contract for study identifiying antibiotic treatment for MRSA
8. Penn researchers discover novel pathway for increasing good cholesterol
9. Theory of facial aging gets a facelift from UT Southwestern researchers
10. UIC researchers to develop new drugs to fight bioterrorism
11. UQ researchers discover some of the oldest forms of life

Post Your Comments:

(Date:3/30/2021)... , ... March 29, 2021 , ... ... the 21st Century , A Virtual Workshop Presented by WCG FDAnews and Cerulean ... 4:30 pm EDT, https://wcg.swoogo.com/modern-sop-and-quality-systems , Are one’s SOPs written for the ...
(Date:3/30/2021)... ... March 29, 2021 , ... According to data released ... reproductive age (13-44) in need of publicly funded contraception live in counties impacted by ... Colorado’s 64 counties have lost some of their Title X resources. , The ...
(Date:3/30/2021)... ... March 29, 2021 , ... Health Literacy Innovations (HLI), a ... confusion due to low health literacy today announces a new partnership with the ... work with ACAP’s member Safety Net Health Plans, those that provide comprehensive health ...
(Date:3/30/2021)... ... ... Dr. Colin Campbell is proud to announce the 1 year anniversary in their new state ... internal medicine and is a primary care specialist who has been practicing for 23 years. ... keep South Jersey healthy one patient at a time. , “Over the past year, Dr. ...
(Date:3/30/2021)... ... March 30, 2021 , ... The COVID-19 ... and survivors; their families; and their caregivers. Crossroads4Hope is addressing the needs of ... emotional support system, MyGo2Support, which meets needs of people impacted by cancer, no ...
Breaking Medicine News(10 mins):
(Date:3/30/2021)... ... March 29, 2021 , ... The University of Texas Health Science Center ... San Antonio Multispecialty and Research Hospital, a destination center for research and treatment of ... In a nod to the COVID-19 pandemic, the ceremony was held virtually. , William ...
(Date:3/30/2021)... ... March 29, 2021 , ... Iora Health ... primary care, has partnered with Devoted Health , one of the fastest-growing ... across Maricopa County and provides seniors with the highest-quality care and experience possible, ...
(Date:3/30/2021)... CITY (PRWEB) , ... March 29, 2021 , ... ... has joined the Vaccine Credential Initiative (VCI), a group bringing together leading health ... record of vaccination status, based on open, interoperable standards. By joining the VCI ...
Breaking Medicine Technology:
Cached News: