FDA's Clinical Trial Oversight LackingFDA's Clinical Trial Oversight Lacking
FDA has come under fire in a new report for not ensuring the safety of the millions of people who participate in clinical trials. According to a New York Times story, HHS inspector general Daniel R. Levinson said that federal health officials rarely audited testing sites and if they did, the inspectors usually arrived after tests were completed.
October 1, 2007
Of course, there are about 200 inspectors assigned to oversee approximately 350,000 testing sites, so itâEUR(TM)d be virtually impossible to police every site. But the report also found that top officials in Washington downgraded the inspectorsâEUR(TM) findings most of the time and almost never followed up to see if specified corrective actions were taken.
An earlier inspector general report found that inspections focused more on the accuracy of study information and not enough on the protection of human subjects. The new report found that in that regard, nothing has changed.
Not surprisingly, the report essentially concludes that the agency's oversight is disorganized and underfinanced.
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