FDA Not Watching Drug Trial Subjects: Study

Clinical trials that enroll millions of patients in tests of experimental drugs and medical devices get scant government oversight, according to a report released Friday.

Over a six-year period, the Food and Drug Administration inspected just one of every 100 trial sites, raising questions about the agency's ability to ensure the safety of study participants, according to the report by Health and Human Services Department inspector general Daniel Levinson.

Hampered by the lack of a comprehensive catalog of clinical trials, the FDA is unable to even identify all trials, the estimated 350,000 study sites and the institutional review boards that oversee each study to ensure they meet scientific, ethical and legal obligations, the report says.

Those limitations hinder the FDA's ability to ensure participants are protected from unreasonable risks, Levinson said.

The FDA relies on just 200 inspectors to police human studies of drugs and devices. The inspections they perform focus more on ensuring the accuracy of trial data than on verifying the measures put in place to protect the study participants, the investigation found.

Even when inspectors do turn up serious problems, their findings are frequently downgraded by senior officials and almost never followed by inspections to see whether the issues have been resolved, according to the report. In the case of the FDA's drug office, 68 percent of inspector recommendations that the agency take regulatory action, typically in the form of a warning letter, were downgraded.

The FDA found serious problems at test sites 348 times between 2000 and 2005. But only 26 investigators were disqualified from conducting further clinical trials, and data were disqualified just twice, according to the report.

"The report makes clear without a tough cop on the beat to enforce the rules, unscrupulous researchers can take advantage of trial participants and potentially expose them to harm," said Rep. Edward Markey, D-Mass., co-author of a provision in an FDA bill signed into law this week that creates a mandatory clinical trial registry.

The FDA told the inspector general that inspections make up only one part of its efforts to ensure human subject are protected. The agency sees its review of study protocols before they get under way as the most important step in protecting participants.

The FDA oversees the safety of companies' drug or medical device trials, while the Office for Human Research Protections does the same for federally financed tests. There is no federal monitoring of privately financed, noncommercial trials.

The study was first reported in The New York Times' Friday editions.