Drug-Coated Stents, Distal Protection Devices: DCRD Explicates DMC Benefits
This article was originally published in The Gray Sheet
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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FDA's guidance on clinical trial data monitoring committees (DMCs) should make clear that device firms need not hire independent statisticians to perform interim analyses, Medtronic writes in Feb. 15 comments to FDA regarding the November 2001 draft guidance
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monitoring committee, Thomas Fleming, PhD, University of Washington, suggested during a Nov. 27 public meeting on FDA's draft guidance on clinical trial data monitoring committees in Bethesda, Maryland
FDA strongly recommends data monitoring committees for early-phase clinical trials where the investigator is also the sponsor, or where subjects may be placed at unusual risk, a Nov. 16 draft guidance on DMCs states