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July 2, 2011. Category: Library Articles

Clinical Trial Participants get little FDA protection

Millions of patients enroll in clinical trials every year for experimental drugs and medical devices, but a federal investigation conducted by Inspector General Daniel R. Levinson of the Department of Health and Human Services has revealed that patients are rarely watched over or receive little or no FDA protection. Although the FDA’s program goals were to ensure dada integrity and protect humans, Levinson found that actual FDA monitoring concerned itself more with verifying data. “We did not find that this process protects human subjects during the research process,” according to Levinson.

According to the investigation results, federal health officials were unaware of how many clinical trials were taking place and less than 1% of testing sites were audited. For example, in 1999, the FDA inspected only 468 testing sites out of nearly 14,000 potentially involved in clinical trials. According to Levinson, part of the reason clinical trials get so little oversight is because the FDA only has around 200 inspectors to police around 350,000 testing sites. Alarmingly, even when inspectors found serious problems, their findings were usually downgraded by higher officials, and usually FDA inspectors almost never went back to the testing site to determine whether corrective actions had been taken. In order to improve the current system, Levinson recommended that the FDA create a registry of all continuing clinical trials and create a database to reach all research inspections.

The new FDA drug safety bill recently signed into law not only grants the FDA more funds and powers, but the bill finally includes a provision for a clinical trial registry. The new law also requires an increase of fees the health care industry would need to pay to fund product reviews. Pharmaceutical and medical device manufacturers are expected to pay nearly $393 million in 2008, up from just $87 million paid in 2007.

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