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The importance of PRO measures in clinical trials for new drugs, biological agents, and devices was underscored by the release of the US Food and Drug Administration's draft guidance for industry titled "Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims".
The U.S. Food and Drug Administration FDAA) 2006 draft guidance on "Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims" has engendered wide discussion about patient-reported outcome (PRO) domains that should be endpoints in clinical trials.
The FDA's guidance for industry titled Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims (hereafter called FDA's PRO Guidance) [8] refers to the importance of comparability of content validity and other measurement properties across all language versions of a PRO measure.
In particular, the United Stated Food and Drug Administration FDAA) released the "Guidance for Industry on Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims," which emphasizes the need to demonstrate an instrument's content validity [ 12].
The US Department of Health and Human Services Food and Drug Administration FDAA) made public in February 2006 a document entitled 'Guidance for Industry Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims DRAFT GUIDANCE'.
The conduct of the study was guided by the methods described in the US Food and Drug Administration FDAA) Guidance for Industry Patient-Reported Outcome (PRO) Measures: Use in Medical Product Development to Support Labeling Claims [ 16] and the ISPOR Task Force Reports on best practice for establishing and reporting on content validity of a new PRO instrument [ 17].
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Each report under subparagraph (A) shall include all information necessary to relate and compare the conditions and service measures used in the previous biennial reports to conditions and service measures used in the current report.
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