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Statistical Considerations for Patient-Reported Outcomes Keywords: FDA, patient-reported outcomes, guidance, interpretation, analysis In February 2006, the Food and Drug Administration (FDA) released a draft guidance on patient-reported outcomes (PROs) for use in medical product development to support labeling claims. Researchers at the Mayo Clinic convened with FDA personnel and experts from academia and industry to facilitate discussion, dissemination, and operationalization of the FDA draft document. Key topics were discussed at this meeting and subsequently published in a special issue of Value in Health [2007;10(suppl. 2)]. Statistical considerations for PROs were among the key topics and are the focus of the current presentation. This presentation covers several areas of statistical import – missing data, multiplicity, design issues, clinical significance, and interpretation of results –for consideration in the design, analysis, and interpretation of PROs for a regulatory label claim.
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