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