Clinical Drug Trials: FDA Fails to Monitor Safety and Integrity

Thursday, October 18, 2007 by: Herb Newborg

(NewsTarget) A new report issued on September 28th, 2007 by Department of Health and Human Services Office of Inspector General found that federal health officials don't even know how many clinical trials are being conducted in the US . The report said the FDA has 200 inspectors (some part time employees) to police an estimated 350,000 testing sites.

It estimated that only 1 percent of all clinical trials were audited between 2000 and 2005. During the period between 2000 and 2005 - of the estimated 350,000 trial sites the FDA was believed to have inspected just 2,855.

The report also found there was a lack of follow ups on sites which had been issued a warning letter after being classified as 'official action indicated' (OAI) for violations of regulatory significance.

The FDA must re-inspect sites that have been sent a warning letter to ensure there are no repeat violations, but according to FDA data, which was noted to be inadequate by the report, the agency only conducted three follow-ups for every 100 inspections that were classified as OAI or voluntary action indicated (VAI).

Other statistics showed that of the 348 OAIs classified by the FDA only 26 were disqualified from further clinical trials and only two had their data disqualified. Seventy percent received a warning letter, relying heavily on voluntary compliance to correct regulatory violations.

Many OAI recommendations were also downgraded to a classification where violations did not have to be formally addressed.

The FDA also was faulted for failing to make sure that any problems found are properly addressed.

The FDA oversees the safety of trials by companies seeking approval to sell drugs or devices. There is no federal oversight for private, noncommercial trials. The inspector general's report calls for the creation of a comprehensive database of all clinical trials, a federal registry of clinical trial inspectors and increased legal oversight.

Equally as important as the integrity of the research data is the safety of the human subjects participating in these clinical trials.

“In many ways, rats and mice get greater protection as research subjects in the United States than do humans,” said Arthur L. Caplan, chairman of the department of medical ethics at the University of Pennsylvania .

Animal research centers have to: register with the federal government, keep track of subject numbers, have unannounced spot inspections and address problems speedily or risk closing, none of which is true in human research, according to Mr. Caplan.

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

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