The Missing Details of Your Missing Data Analysis Plan
View Presentation *Alvin VanOrden, FDA Keywords: If missing data is not analyzed appropriately, it can lead to major deficiency letters from the FDA (some examples to be provided), which increases the costs and time to approval (or disapproval). So with so many methods available for the analysis of missing data, what is the right way (or FDA approvable way) of analyzing missing data? How can you make the process as painless as possible for both the sponsor and the FDA? In this talk, I will present the top 3 mistakes in the analysis of missing data, and easy ways to avoid them. I will emphasize practical solutions and simple, but often overlooked, ideas for helping your submission pass FDA inspection. Examples and suggestions will be given for a variety of endpoints, focusing on problems commonly seen in medical devices.
|
Key Dates
-
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