When the U.S. Food and Drug Administration (FDA) identifies problems in its inspections of clinical sites where biomedical research is performed on human subjects, those findings seldom are reflected in peer-reviewed literature later written about the research, according to a study by the Arthur L. Carter Journalism Institute.

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“Since the FDA’s evidence of misconduct -- even of fraud -- seldom makes its way into the peer-reviewed literature, researchers and doctors are unaware that they’re making life-and-death decisions based upon experiments whose reliability has been called into question,” explains Professor Charles Seife, the study’s author.

The findings appear in the latest issue of JAMA Internal Medicine.

The research stems from an investigative reporting class Seife teaches at the Carter Journalism Institute. Students enrolled in the Institute’s Science, Health, and Environmental Reporting (SHERP) program participated in the research by matching FDA inspections with subsequent peer-reviewed articles.

The FDA classifies its inspections based on the severity of the violations that are found; the most severe is “official action indicated (OAI),” which means objectionable conditions or practices were found that warrant regulatory action. During the 2013 fiscal year, about 2 percent of the 644 inspections the FDA carried out at trial sites were classified as OAI, according to background information in the study.

Seife and his students identified published clinical trials where an FDA inspection found significant problems and determined whether there was mention of it in peer-reviewed medical literature.

The researchers identified 57 published clinical trials where an FDA inspection found one or more of the following problems: falsification or submission of false information, 22 trials (39 percent); problems with adverse events reporting, 14 trials (25 percent); protocol violations, 42 trials, (74 percent); inadequate or inaccurate recordkeeping, 35 trials (61 percent); failure to protect the safety of patients and/or issues with oversight or informed consent, 30 trials (53 percent); and violations that were not otherwise characterized, 20 trials (35 percent). Only three of the 78 publications (4 percent) that resulted from the trials where the FDA found significant violations mentioned the objectionable conditions or practices.

“The FDA does not typically notify journals when a site participating in a published clinical trial receives an OAI inspection, nor does it generally make any announcement intended to alert the public about the research misconduct that it finds,” the study concludes. “The documents the agency discloses tend to be heavily redacted. As a result, it is usually very difficult, or even impossible, to determine which published clinical trials are implicated by the FDA’s allegations of research misconduct.”

Visit the Arthur L. Carter Journalism Institute's website, for more information.
 

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