The article examined the coflex Investigational Device Exemption Study from Paradigm Spine. A Clinical Events Committee independent of the study sponsor reviewed and reclassified all adverse event reports submitted by investigators. Around 37 percent of the adverse events were reclassified, and the CEC was 5.3 times more likely to upgrade than downgrade the adverse event.
The article’s authors, led by Joseph D. Auerbach, MD, of the Department of Orthopaedics, Bronx-Lebanon Hospital Center, Albert Einstein College of Medicine in New York City, concluded that the “status of the investigator’s financial interest in the company had little effect on the reclassification of adverse events.”
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