Abstract
This article provides a practical guide for clinical researchers to incorporate and assess patient-reported outcomes (PROs) in a clinical trial for regulatory purposes, including for a label claim, drug promotion, and program planning. We provide six fundamental steps for evaluating PROs in clinical trials: 1) formulating study objectives, 2) developing or selecting an instrument, 3) developing data collection strategies, 4) analyzing data, 5) reporting data, and 6) interpreting study findings. Patient-reported outcomes should be handled like other clinical study endpoints, be integrated into the statistical analysis plan, and adopt the same set of scientific standards.
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