Statistical Analysis Plans - Keeping development plans on track by resolving the disconnect between the FDA and Sponsors
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*Paul Flyer, Pacific Northwest Statistical Consulting, Inc. 

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FDA has recently been requesting that Statistical Analysis Plans (SAPs) be submitted at the same time as protocols. Fulfilling this request can result in a delay in starting the protocol or the sponsor choosing to not have the FDA review the protocol. These choices are not necessary. There is a lack of agreement on the statistical/regulatory role of the SAP versus the role of the SAP as an operational document. This talk will provide a historical context for these competing views and suggest an alternative approach to the specification of statistical analyses.