Clinical events committee: an effective tool in reducing bias in industry-funded studies .
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Mitigating adverse event reporting bias in spine surgery
J Bone Joint Surg Am. 2013 Aug 21;95(16):1450-6A previous study funded by Paradigm Spine, containing 322 patients who were scheduled to receive treatment of spinal stenosis with a Coflex implant (Paradigm spine product) or a conventional spinal fusion, was re-analyzed by an independent clinical events committee (CEC) to see if the classification of adverse events within the study were appropriate and to determine if the presence of investigators with financial interest in the study had an effect on the validity of classifications. 37% of adverse events were reclassified by the CEC, with a large majority of the reclassifications being an upgrade in severity or a designation of greater relatedness to the surgery or device. No significant effect of company interest or the financial interest of investigators on classification of adverse events was found by the independent CEC.
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