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A regulatory view

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Quality of Life Assessment: Key Issues in the 1990s

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Abstract

Improvement in quality of life (QOL) is an important objective of treatment for many illnesses. Thus the United States Food and Drug Administration (FDA) is interested in assessing the effect of new drugs on QOL. There has been more internal FDA discussion and more collaboration with industry and academia on QOL assessment in cancer than other diseases. Cancer will be used in this chapter as a model for describing the FDA perspective on QOL assessment in clinical trials.

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References

  1. Gelber, R.D. and Goldhirsch, A. A new endpoint for the assessment of adjuvant therapy in postmenopausal women with operable breast cancer.J. Clin. Oncol. 1986;4: 1772–1779.

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  3. Shoemaker, D., Burke, G., Dorr, A. et al. A regulatory perspective. In Spilker, B. (ed.) Quality of Life Assessments in Clinical Trials. New York, Raven Press, 1990, pp. 193–201.

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Authors
  1. J. R. Johnson
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Editors and Affiliations

  1. Welsh School of Pharmacy, University of Wales College, Cardiff, UK

    Stuart R. Walker (Director of the Centre for Medicines Research, Carshalton, and Honorary Professor) (Director of the Centre for Medicines Research, Carshalton, and Honorary Professor)

  2. University College and Middlesex School of Medicine, London University, London, UK

    Rachel M. Rosser (Professor of Psychiatry and Head of Department) (Professor of Psychiatry and Head of Department)

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© 1993 Springer Science+Business Media Dordrecht

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Johnson, J.R. (1993). A regulatory view. In: Walker, S.R., Rosser, R.M. (eds) Quality of Life Assessment: Key Issues in the 1990s. Springer, Dordrecht. https://doi.org/10.1007/978-94-011-2988-6_24

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  • DOI: https://doi.org/10.1007/978-94-011-2988-6_24

  • Publisher Name: Springer, Dordrecht

  • Print ISBN: 978-94-010-5328-0

  • Online ISBN: 978-94-011-2988-6

  • eBook Packages: Springer Book Archive

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