Inspector General: FDA flunking clinical trials oversight

A linkurl:report;http://www.oig.hhs.gov/oei/reports/oei-01-06-00160.pdf released today by the Department of Health and Human Services reveals that the linkurl:FDA;http://www.the-scientist.com/article/display/36885/ is woefully lax in monitoring clinical trials research, according to the linkurl:New York Times.;http://www.nytimes.com/2007/09/28/health/policy/28fda.html?ref=healthThe article reports that agency officials don't know how many clinical trials are going, and that just 200 inspecto

Alla Katsnelson
Sep 27, 2007
A linkurl:report;http://www.oig.hhs.gov/oei/reports/oei-01-06-00160.pdf released today by the Department of Health and Human Services reveals that the linkurl:FDA;http://www.the-scientist.com/article/display/36885/ is woefully lax in monitoring clinical trials research, according to the linkurl:New York Times.;http://www.nytimes.com/2007/09/28/health/policy/28fda.html?ref=healthThe 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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