Patient-Reported Outcomes to Support Medical Product Labeling Claims: FDA Perspective
Article first published online: 8 NOV 2007
Value in Health
Special Issue: The FDA Guidance for Patient-Reported Outcomes
Volume 10, Issue Supplement s2, pages S125–S137, November/December 2007
How to Cite
Patrick, D. L., Burke, L. B., Powers, J. H., Scott, J. A., Rock, E. P., Dawisha, S., O'Neill, R. and Kennedy, D. L. (2007), Patient-Reported Outcomes to Support Medical Product Labeling Claims: FDA Perspective. Value in Health, 10: S125–S137. doi: 10.1111/j.1524-4733.2007.00275.x
- Issue published online: 8 NOV 2007
- Article first published online: 8 NOV 2007
- 1US Food and Drug Administration. Guidance for Industry: Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims. Available from: http://www.Fda.Gov/Cder/Guidance/5460dft.Pdf[Accessed May 4, 2007]. Federal Register: February 3, 2006, Vol. 71. Number 23) Docket no. 2006D−0044.
- 6Quality of Life: The Assessment, Analysis, and Interpretation of Patient-Reported Outcomes, 2nd edn. New York: Wiley, 2007., , eds.
- 8Coefficient alpha and the internal structure of test. Psychometrika 1951;16:297–334.
- 10Health Status and Health Policy: Quality of Life in Health Care Evaluation and Resource Allocation. New York: Oxford University Press, 1993.,
- 13Context Effects in Social and Psychological Research. New York: Springer-Verlag, 1992., , eds.
- 14Questions and Answers in Attitude Surveys. New York: Academic Press,1981.,
- 15Survey Methodology. New York: Wiley, 2004., , Jr, , et al.
- 16US Food and Drug Administration. ICH E9 ‘Statistical Principles for Clinical Trials.’ Available from: http://www.fda.gov/cder/guidance/ICH_E9-fnl.pdf[Accessed May 4, 2007].
- 17The European Agency for the Evaluation of Medicinal Products. Committee for Proprietary Medical Products: ‘Points to consider on multiplicity issues in clinical trials.’ Available from: http://www.emea.eu.int/pdfs/human/ewp/090899en.pdf[Accessed May 4, 2007].
- 18Design and Analysis of Quality of Life Studies in Clinical Trials. Boca Raton, FL: Chapman and Hall/CRC Press, 2002..
- 20Premarin® Product Labeling. November 2005.
- 21Aricept® Product Labeling. March 2005.