Developing Best Practices Regarding Statistical Analysis Plans
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*Mary E Nilsson, Eli Lilly & Company 

Keywords: SAP, Statistical analysis plan

There is a need to establish best practices and/or standard operating procedures regarding statistical analysis plans. There is increased awareness among regulatory agencies about the importance of statistical analysis plans. In addition, companies may want to establish a consistent process for developing statistical analysis plans to increase efficiency and for resource planning purposes. There are some, but not many, discussion papers on the topic. In this talk, different viewpoints of how a statistical analysis plan should be defined, how it should be formatted, and when it should be created will be discussed.