Integrated Summary of Effectiveness/Safety: Statistical Implementation Suggestions
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*Mary E. Nilsson, Eli Lilly & Company 


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.