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FDA Data Monitoring Cmte. Final Guidance Will Detail Role Of Statistician

This article was originally published in The Gray Sheet

Executive Summary

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monitoring committee, Thomas Fleming, PhD, University of Washington, suggested during a Nov. 27 public meeting on FDA's draft guidance on clinical trial data monitoring committees in Bethesda, Maryland

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