Beyond the FDA PRO Guidance: Steps toward Integrating Meaningful Patient-Reported Outcomes into Regulatory Trials and US Drug Labels

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Bibliographic Details
Published in:Value in health 2012-05, Vol.15 (3), p.401-403
Main Author: Basch, Ethan, MD, MSc
Format: Article
Language:English
Subjects:
Clinical Trials as Topic - methods
Drug Labeling
Guidelines as Topic
Humans
Internal Medicine
Outcome Assessment (Health Care) - methods
Patient Participation
Quality of Life
Self Report
United States
United States Food and Drug Administration
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ISSN:1098-3015
1524-4733
DOI:10.1016/j.jval.2012.03.1385