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


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.