[IEEE-bhpjobs] Duke (DCRI) and FDA put Clinical Trials on the Examining Table

[Esther Lumsdon]

Duke University Medical Center and the FDA are set to launch a
partnership to try to improve the nation's clunky clinical-trials
process.

A recent report from the inspector general of the FDA's parent agency,
the Department of Health and Human Services, estimated that the agency
inspects only around one percent of clinical trial sites. The FDA also
struggles to track trials, and its "guidance and regulations don't
reflect current clinical trials practices" the report says.

Robert Califf, a cardiologist and vice chancellor for clinical
research at Duke, will chair the public-private partnership. "We know
it needs to be done differently than how it's done now," Califf told
the Health Blog. A typical clinical outcomes trial costs around $500
million, he says, and much of that is wasted on unnecessary or
inefficient practices. He says the group will involve academic
researchers and the agency, but also industry and patient
representatives.

The FDA's Rachel Behrman, director of the agency's office of critical
path programs, will co-chair the effort.

http://blogs.wsj.com/health/2007/11/20/duke-fda-put-clinical-trials-on-the-examining-table/

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Esther L, estherlist at gmail.com
"A dirty car is a sign of civic responsibility nowadays." Mike Easley,
NC Governor