FDA Issues in Trials Often Unreported in Literature

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FDA Issues in Trials Often Unreported in Literature
FDA Issues in Trials Often Unreported in Literature

(HealthDay News) -- A review of U.S. Food and Drug Administration inspection reports between 1998 and 2013 revealed 57 clinical trials in which regulators had uncovered violations serious enough to earn the agency's most severe classification -- "official action indicated," or OAI. The findings were published online Feb. 9 in JAMA Internal Medicine.

Seventy-eight articles were published based on data from these trials. But only three of them mentioned the violations that regulators found, Charles Seife, a professor at the Arthur L. Carter Institute of Journalism at New York University in New York City, and a team of graduate students determined. The violations included fraud, incompetence, or misconduct.

The good news is that such violations are rare, Seife told HealthDay. During the 2013 fiscal year, about 2 percent of the 644 inspections the FDA carried out at clinical trial sites were classified as OAI, according to background information in the study. But when these violations are uncovered, they can be serious enough to undermine the findings reported from the clinical trial. For example: The FDA deemed an entire trial devoted to the blood-thinning drug rivaroxaban unreliable, due to systematic and widespread scientific fraud. Despite this, the findings from the trial were published in a journal with no mention of the FDA's condemnation.

The FDA inspections uncovered one or more violations in the 57 published clinical trials identified by Seife and his students, including: 22 trials with falsified information; 14 trials where researchers failed to report adverse events; 42 trials with violations of the trial's protocols; 35 trials with record-keeping errors; and 30 trials in which researchers failed to protect patient safety or acquire informed consent. "Is this an issue that is affecting the quality of the peer-reviewed literature? You definitely can say that," Seife said.

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