Beyond the FDA PRO Guidance: Steps toward Integrating Meaningful Patient-Reported Outcomes into Regulatory Trials and US Drug Labels
Author:
Publisher
Elsevier BV
Subject
Public Health, Environmental and Occupational Health,Health Policy
Reference4 articles.
1. A review of patient-reported outcomes labels in the US: 2006–2010;DeMuro;Value Health,2013
2. Multinational Trials—Recommendations on the Translations Required, Approaches to Using the Same Language in Different Countries, and the Approaches to Support Pooling the Data: The ISPOR Patient-Reported Outcomes Translation and Linguistic Validation Good Research Practices Task Force Report
3. Content validity–establishing and reporting the evidence in newly developed patient-reported outcomes (PRO) instruments for medical product evaluation: ISPOR PRO Good Research Practices Task Force report: part 2–assessing respondent understanding;Patrick;Value Health,2011
4. The missing voice of patients in drug-safety reporting;Basch;N Engl J Med,2010
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