DATA MONITORING OF GLOBAL TRIALS: SOME GENERAL ISSUES AND A CASE STUDY
View Presentation *Susan Ellenberg, University of Pennsylvania Keywords: DMC, global trial, benefit-risk, monitoring, ethics Global trials present special challenges to data monitoring committees (DMCs). Balancing ethical issues with scientific considerations is always in the remit of a DMC, but in a trial in which there may be widely varying perspectives on ethical considerations, finding this balancing can be difficult. A DMC for a global trial should ideally include members who are aware of and sensitive to these varying perspectives and can incorporate them into discussions and evaluations of the emerging data. In some cases, especially when trials are conducted in developing countries, practical and financial considerations may also arise in DMC decision-making. Specific cases illustrating how DMCs struggle with these issues will be presented.
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Key Dates
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November 1 - December 17, 2013
Online proposal submission for a session, short course and Town Hall Open -
January 6 - March 11, 2014
Online proposal submission for Roundtables Open -
April 30 - May 28, 2014
Abstract Submission Open -
June 4, 2014
Online Registration Opens -
August 8 - August 22, 2014
Invited Abstract Editing -
August 11, 2014
Short Course materials due from Instructors -
September 1, 2014
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September 15, 2014
Cancellation Deadline and Registration Closes @ 11:59 pm EDT -
September 22 - September 24, 2014
Marriott Wardman Park, Washington, DC