The Missing Voice of Patients in Drug-Safety Reporting

Abstract

[...]patient self-reporting as a data-collection method was recently embraced by the FDA in its "Guidance for Industry: Patient-Reported Outcome Measures Use in Medical Product Development to Support Labeling Claims," in which "patient-reported outcomes" -- a term that broadly refers to any data directly reported by patients without interpretation by someone else -- are characterized as the standard method for assessing subjective phenomena that are best described by the patient, such as symptoms.