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Drug-Coated Stents, Distal Protection Devices: DCRD Explicates DMC Benefits

This article was originally published in The Gray Sheet

Executive Summary

Device firms employing data monitoring committees to evaluate clinical trials should ensure that DMCs operate under a clearly defined protocol, according to CDRH's Division of Cardiovascular & Respiratory Devices

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Clinical trial integrity may be best protected by relying on a blinded statistician to advise the sponsor on study design and an unblinded one to report to the data monitoring committee, Thomas Fleming, PhD, University of Washington, suggested during a Nov. 27 public meeting on FDA's draft guidance on clinical trial data monitoring committees in Bethesda, Maryland

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