Challenges facing FDA statisticians in their reviews of submissions containing patient-reported outcomes (PROs)
View Presentation *Lisa A. Kammerman, FDA Keywords: patient-reported outcomes, validation, interpretation Although FDA's guidance on patient-reported outcomes (PROs) provides advice on the quantitative and statistical aspects of PROs and the data they generate, their review by FDA statisticians presents many challenges. I will present recent case studies that illustrate some of the challenges that statistical reviewers encounter when they evaluate the validation of instruments and interpret the results of studies that use PROs. These case studies will also identify areas that require further thought and development.
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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