|Articles|January 12, 2009

Office of Inspector General Report

Office of Inspector General's report on the FDA's oversight of clinical investigators' financial information.

The U.S. Department of Health and Human Services' Office of Inspector General has published a report, "The Food and Drug Administration's Oversight of Clinical Investigators' Financial Information," which can be found at:

http://oig.hhs.gov/oei/reports/oei-01-07-00450.pdf


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The clinical research industry talks about patient-centeredness constantly but embeds it too late, too narrowly, and without clear ownership, and the cost shows up in enrollment failures, protocol deviations, and outcomes that don't reflect what patients actually care about.