Defining Treatment Response as Measured by PRO Instruments
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*Laurie Burke, FDA 

Keywords: Patient Reported Outcomes, Responder Analyses

Laurie Burke, from the FDA (Study Endpoints and Labeling, OND) has worked extensively in the development of the PRO draft guidance document. Her presentation will introduce the PRO guidance document and will then discuss the particular focus for this session. Of specific interest is the definition and analysis of treatment response as measured by PRO instruments.