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Quality of Life Research

, Volume 24, Issue 7, pp 1585–1586 | Cite as

Content validity and legacy patient-reported outcome measures in cancer

  • Adam B. Smith
  • Kim Cocks
Commentary

Keywords

Melanoma Guidance Document Comparative Effectiveness Research Appetite Loss Label Claim 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

References

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    US Department of Health and Human Services. Guidance for industry: Patient-reported outcome measures: use in medical product development to support labeling claims. December 2009, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM193282.pdf.
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    DeMuro, C., Clark, M., Mordin, M., Fehnel, S., Copley-Merriman, C., & Gnanasakthy, A. (2012). Reasons for rejection of patient-reported outcome label claims: A compilation based on a review of patient-reported outcome use among new molecular entities and biologic license applications, 2006–2010. Value in Health., 15, 443–448.PubMedCrossRefGoogle Scholar
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    DeMuro, C., Clark, M., Doward, L., Evans, E., Mordin, M., & Gnanasakthy, A. (2013). Assessment of PRO label claims granted by the FDA as compared to the EMA (2006–2010). Value in Health, 16, 1150–1155.PubMedCrossRefGoogle Scholar
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    Reeve, B.B., Mitchell, S.A., Dueck, A.C., Basch, E., Cella, D., Reilly, C.M., Minasian, L.M., Denicoff, A.M., O’Mara, A.M., Fisch, M.J., Chauhan, C., Aaronson, N.K., Coens, C., Bruner, D.W. (2014). Recommended patient-reported core set of symptoms to measure in adult cancer treatment trials. Journal of National Cancer Institute, 106(7).Google Scholar

Copyright information

© Springer International Publishing Switzerland 2014

Authors and Affiliations

  1. 1.York Health Economics Consortium, Market SquareUniversity of YorkYorkUK
  2. 2.York Trials Unit, Department of Health SciencesUniversity of YorkYorkUK

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