Integrated Summary of Effectiveness/Safety: Statistical Implementation Suggestions
View Presentation *Mary E. Nilsson, Eli Lilly & Company Keywords: The speaker will give a15-minute presentation; focusing on the industry's views on the content and objectives of the ISE and ISS. As briefly presented blew, she will discuss the industry challenges for preparation of ISE and ISS: The Integrated Summary of Effectiveness and Integrated Summary of Safety are key submission documents that require statistical thinking and planning. Strategies associated with pooling studies and associated statistical methods are not always straightforward. Also, defining the scope of analyses to perform can be challenging. It is also necessary to define pooling strategies and analyses early in the process in order to incorporate feedback prior to conducting the analyses. Suggestions on process will be provided.
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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