TL37: The Actual Practice of Randomization Management
*Michael T Collins, ICON Clinical Research
This roundtable will discuss how statistically valid methods are applied to common misrandomization cases within a clinical trial. These methods are applied within the IVR/IWR while maintaining scientific integrity in order to best define the intent to treat, per protocol, and safety analysis populations.
We will seek to answer the questions:
(1) How can we maintain treatment balance within a randomization schedule when randomization errors threaten the treatment ratio?
(2) How does the communication path between the sponsor and the protocol statistician facilitate the handling of misrandomization cases?
(3) How can we provide a simple yet powerful audit trail that is helpful during study closeout, data analysis, and study audit?
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
September 9, 2013
Cancellation Deadline and Registration Closes @ 11:59 pm EDT
September 16 - September 18, 2013
Marriott Wardman Park, Washington, DC