Guidance for Using Patient-Reported Outcome Measures in Medical Product Development
Author Information
Author(s): Laurie Burke, Toni Stifano
Primary Institution: U.S. Department of Health and Human Services, Food and Drug Administration
Conclusion
The FDA provides guidance on how to effectively use patient-reported outcome measures to support labeling claims for medical products.
Supporting Evidence
- Patient-reported outcome measures capture the patient's perspective on treatment benefits.
- Guidance aims to streamline FDA review processes for product labeling claims.
- PRO instruments can measure both symptoms and functional impacts of treatments.
Takeaway
This document helps companies understand how to measure what patients think about their treatments, so they can show that their products work well.
Methodology
The guidance outlines the evaluation of patient-reported outcome instruments and their use in clinical trials.
Potential Biases
Potential biases may arise from subjective patient responses and the interpretation of those responses.
Limitations
The guidance does not establish legally enforceable responsibilities and is meant as recommendations.
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