A new report has criticised the way the US government monitors clinical trials that are used to test experimental drugs and medical devices.
The report found that over a six-year period, the FDA inspected just one out of every 100 trial sites, and the document questions the agency’s ability to ensure the safety of people taking part in the studies.
The report, by Health and Human Services Department inspector-general Daniel Levinson, claims the FDA is unable to identify all of the trials that are taking place, 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 FDA relies on 200 inspectors to police human studies of drugs and devices, and the report found that inspections focus more on ensuring the accuracy of trial data than on verifying measures put in place to protect study participants.
And the report claims that even when inspectors do identify serious problems, their findings are frequently downgraded by senior officials and almost never followed by inspections to see whether issues have been resolved.
In the case of the FDA’s drug office, 68% of inspector recommendations suggesting the agency take regulatory action were downgraded.
However, the FDA told the inspector-general that inspections make up only one part of its efforts to ensure participants are protected, and said it sees its review of study protocols before they get under way as the most important step in protecting those who take part in the trials.
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