For Immediate Release
Contact: Bob Beard
434-992-4490
bobbeard@virginia.edu
UVa HEALTH SYSTEM WINS ETHICS GRANT TO
STUDY MONITORING OF DRUG TRIALS
CHARLOTTESVILLE, Va., July 12, 2006 - Jonathan Moreno, Ph.D., and Patti Tereskerz, Ph.D., J.D., at the University of Virginia's Program in Ethics and Policy in Healthcare in the Center for Biomedical Ethics, have been awarded a $77,000 grant by the Greenwall Foundation to study the committees responsible for the safety monitoring of human experiments. The study may lead to the first data on the feasibility and propriety of procedures used by data monitoring committees (DMCs) that monitor clinical trials of new drugs for safety and efficacy. Millions of Americans every year enroll in clinical trials. The study seeks to identify the ethical and legal implications of current and proposed DMC organization and practices before bad results occur.
"It is surprising that the structure and management of data monitoring committees raise ethical issues that have not been resolved, often leaving those who put these committees together and run them in a quandary," Tereskerz said. "There have been more than a few recent accounts of clinical trials that have gone bad, including Vioxx and a recent nightmare in Britain with a genetically engineered drug, that point to the critical role those who monitor clinical trials play."
The research provides an opportunity to employ an innovative, proactive approach to address emerging ethical issues concerning the organization and operation of DMCs. The information generated by this approach should enlarge the capacity for decision-making by the National Institutes of Health and the Food and Drug Administration, Tereskerz said.
Reporters can contact Patti Tereskerz for interviews at (434) 243-6659.