US FDA fails to reveal concerns over clinical trial falsification

Some 22 clinical trials over 15 years have been affected by falsification, according to figures from the US Food and Drug Administration in research published by JAMA Internal Medicine.

Official action due to “significant departures from good clinical practice” was taken against a total of 57 clinical trials, including the 22 affected by “falsification”. However, the report authors found that there was little evidence that these concerns were ever made public. The documents were revealed through freedom of information requests to the FDA made by author Charles Seife, who compared the FDA official actions against all the available peer-reviewed studies on the clinical trials affected from 1998 to 2013.

Prof Seife wrote on the Slate blog: “That misconduct happens isn’t shocking. What is: When the FDA finds scientific fraud or misconduct, the agency doesn’t notify the public, the medical establishment, or even the scientific community that the results of a medical experiment are not to be trusted."