Challenges facing FDA statisticians in their reviews of submissions containing patient-reported outcomes (PROs)
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*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.