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Report faults FDA on clinical trial audits

Safety of millions called at risk

WASHINGTON - The Food and Drug Administration does very little to ensure the safety of the millions of people who participate in clinical trials, a federal investigator has found.

In a report due to be released today, the inspector general of the Department of Health and Human Services, Daniel R. Levinson, said federal health officials do not know how many clinical trials are being conducted, audit less than 1 percent of the nation's testing sites, and, on the rare occasions when inspectors do appear, generally show up long after the tests are completed.

The FDA has only 200 inspectors, some of whom audit clinical trials part time, to police an estimated 350,000 testing sites. Even when those inspectors found serious problems in human trials, top drug officials in Washington downgraded their findings 68 percent of the time, the report found. Among the remaining cases, the agency almost never followed up with an inspection, the report found.

Since no one collects the data systematically, there is no way to tell how safe the nation's clinical research is or ever has been.

The FDA only oversees the safety of trials done by companies seeking approval to sell drugs or devices. The Office for Human Research Protections oversees trials financed by the federal government.

Privately financed noncommercial trials have no federal oversight.

The FDA disqualified investigators from conducting further clinical trials 26 times between 2000 and 2005 and disqualified their data twice even though the agency found serious problems at trial sites 348 times during the period, the inspector general found.

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