Data Monitoring Committees in the 21st Century: A Regulatory Perspective
View Presentation *Gregory Campbell, Food and Drug Administration Keywords: Data Safety Monitoring Board (DSMB), interim monitoring, group sequential monitoring In the over five years since FDA finalized “Guidance for Clinical Trials Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees,” there have been a number of methodological and scientific developments that could cause the reexamination of the basic tenets and the details of the guidance. The main points of the DMC guidance are briefly reviewed. The independence of the DMC and of a third-party statistician, which were a bit controversial when the draft guidance first came out, is revisited. In the past few years a great deal more attention has been focused on enrichment and adaptation of clinical trials. Issues of verifiable firewalls and logistical problems are discussed. The FDA guidance has an expiration date of June, 2012.
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Key Dates
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April 30 - May 22, 2013
Invited Abstract Submission Open -
June 4, 2013
Online Registration Opens -
August 9 - August 23, 2013
Invited Abstract Editing -
August 23, 2013
Short Course materials due from Instructors -
August 26, 2013
Housing Deadline -
September 9, 2013
Cancellation Deadline and Registration Closes @ 11:59 pm EDT -
September 16 - September 18, 2013
Marriott Wardman Park, Washington, DC