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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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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© 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
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