Thursday, February 12, 2015

FDA fails to report fraud in clinical trials – study

Published time: February 10, 2015 05:03Reuters / Michael Buholzer

Reuters / Michael Buholzer
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The Food and Drug Administration (FDA) routinely fails to report evidence of fraud or misconduct when it inspects the way researchers conduct clinical trials, leaving the public unaware of which research is credible and which isn’t.

Researchers at New York University found that in dozens of published papers where the FDA had uncovered faults in clinical trials, only three ever indicated that violations occurred. In a stem cell trial, for example, all patients were said to have experienced improvement – despite one having a foot amputated.

The New York University study examined 57 clinical trials that received a notice of violation from the FDA for poor record keeping, false information, and poor patient study. Researchers found that findings from those clinical trials were used in 78 published papers – but only in three instances were the faults in the clinical trials mentioned in the papers.

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