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Inspector General: FDA flunking clinical trials oversight
Posted by Alla Katsnelson
[Entry posted at 28th September 2007 07:11 PM GMT]
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A report released today by the Department of Health and Human Services reveals that the FDA is woefully lax in monitoring clinical trials research, according to the New York Times.



The article reports that agency officials don't know how many clinical trials are going, and that just 200 inspectors oversee 350,000 trials. They audited fewer than 1 percent of all sites, generally after the trials were complete, and rarely followed up with trial sites about problems they identified.



The article also notes - and illustrates with a troubling example - that the agency conducts no oversight at all over "privately funded noncommercial" trials, creating a fractured system in which patients subject to ethical abuses have little recourse.


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