What Industry Statisticians Should Know about Patient-Reported Outcomes to Support Label Claims
View Presentation *Joe Cappelleri, Pfizer Keywords: patient-reported outcomes, label claim, interpretation, responder analysis, validity, reliability, psychometrics In December 2009 the Food and Drug Administration released its final guidance on patient-reported outcomes for use in medical product development to support labeling claims. The guidance is expected to engage industry statisticians on a regular basis and it is therefore important that industry statisticians know its contents and how to address them. To that end, this presentation highlights several statistical aspects of patient-reported outcomes to support label claims: general statistical considerations, study design, multiple endpoints and comparisons, composite endpoints, missing data, and measurement properties including validity, reliability, and interpretation.
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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