Statistical Issues in Multiple-Regional Clinical Trials
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*Robert O'Neill, FDA, CDER Keywords: It has been quite common to see clinical trials conducted in multiple regions. Many issues have been identified in trial design and implementation, assessment of regional consistency, interpretation of the trial results, investigator training, … etc. An overview of the issues and a guidance to address these issues will be covered in this talk.
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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
