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July 13, 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.
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