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