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Compliance In Focus
Posted by Lori Karpinecz on Thu, Feb 12, 2015

A Question of Disclosure: FDA Findings and Publications

When the Food and Drug Administration (FDA) identifies significant findings with the conduct ofFDA Findings and Publications a clinical trial during an inspection, what happens to those findings? According to a recent article published online by JAMA Internal Medicine, those findings remain hidden in plain sight.

Charles Seife, MS, a professor at the Arthur L. Carter Institute of Journalism at New York University, conducted a research study that sought to “identify published clinical trials in which an FDA inspection found significant evidence of objectionable conditions or practices, to describe violations, and to determine whether the violations are mentioned in the peer-reviewed literature.”

Violations identified during an FDA inspection are classified into one of 3 levels of severity: No action indicated, in which no substantial violations were identified; voluntary action indicated, in which violations were identified but do not require sanction; and official action indicated (OAI), in which objectionable conditions were found that warrant regulatory action. According to Seife’s study, 2% of the 644 FDA inspections conducted in 2013 resulted in an OAI classification.

The findings identified during these inspections were not surprising, and in fact will look familiar to the findings summarized in our whitepaper on the top FDA warning letter findings in 2013. However, what was surprising to Seife was how little these findings were mentioned in the final, published  trial results. Of the 78 publications Seife and his team were able to link to the OAI-designated studies, only 4% of these publications mentioned the FDA findings in the literature.

In his conclusion Seife writes, “The FDA does not typically notify journals when a site participating in a published clinical trial received an OAI inspection, nor does it generally make any announcement intended to alert the public about the research misconduct that it finds.” While information about FDA inspections is publicly available, it is often heavily redacted to protect the integrity of the clinical trial. As a result, it can be very difficult to connect these OAI classifications to the published clinical trial results—a connection that could call the published data into question.

Seife offers several suggestions to increase FDA transparency but acknowledges that the burden for ensuring the integrity of research published in peer-reviewed literature should fall on the authors of these publications as well as the journals that should make such disclosures a requirement.

Should measures be put into place to increase the transparency in published clinical research? Let us know in the comments below.

Photo Credit: buechertiger

Giving Your Studies a Fair Shake

Topics: Inspections, Charles Selfe, FDA, Warning Letters

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