Skip to main content

Assessing Tumor-Related Symptoms and Health-Related Quality of Life in Cancer Clinical Trials

A Regulatory Perspective

  • Chapter
Anticancer Drug Development Guide

Part of the book series: Cancer Drug Discovery and Development ((CDD&D))

  • 732 Accesses

Abstract

Improving survival has traditionally been the goal of anticancer therapy. Although great strides have been made in cancer therapeutics, it is relatively uncommon that new drugs or biological agents provide substantial improvement in survival. Most of these agents have side effects, some of which are severe, resulting in discomfort and disability. For patients with incurable cancers, overall quality of their remaining life is particularly important. Adequate palliation of cancer-related symptoms, especially pain, may ease suffering and fear, allowing the final journey to be taken with peace and dignity.

This chapter reflects independent work of the authors and does not necessarily represent the view of the Food and Drug Administration.

This is a preview of subscription content, log in via an institution to check access.

Access this chapter

Chapter
USD 29.95
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
eBook
USD 129.00
Price excludes VAT (USA)
  • Available as EPUB and PDF
  • Read on any device
  • Instant download
  • Own it forever
Softcover Book
USD 169.99
Price excludes VAT (USA)
  • Compact, lightweight edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info
Hardcover Book
USD 219.99
Price excludes VAT (USA)
  • Durable hardcover edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Purchases are for personal use only

Institutional subscriptions

Preview

Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.

References

  1. Transcript of the Quality of Life Subcommittee of the Oncologie Drug Advisory Committee to the Food and Drug Administration, February 10, 2000.

    Google Scholar 

  2. Johnson JR, Williams G, Pazdun R. Endpoints for FDA approval of Oncology Drugs. ASCO abstract #1018, 2002.

    Google Scholar 

  3. World Health Organization. The First Ten Years of the World Health Organization. Geneva: WHO. 1958.

    Google Scholar 

  4. Testa MA, Simonson DC. Assessment of quality-of-life outcomes. N Engl J Med 1996; 334: 835–840.

    Article  PubMed  CAS  Google Scholar 

  5. Osoba D. Lessons learned from measuring health-related quality of life in oncology. J Clin Oncol 1994; 12: 608–616.

    PubMed  CAS  Google Scholar 

  6. Wilson IB, Cleary PD. Linking clinical variables with health-related quality of life-a conceptual model of patient outcomes. JAMA 1995; 273: 59–65.

    Article  PubMed  CAS  Google Scholar 

  7. Beitz J. Quality-of-life endpoints in oncology drug trials. Oncology 1999; 13: 1439–1445.

    PubMed  CAS  Google Scholar 

  8. Aaronson NK. Methodologic issues in assessing the quality of life of cancer patients. Cancer 1991; 67 (3 suppl): 844–850.

    Article  PubMed  CAS  Google Scholar 

  9. Gnecco C, Lachenbruch PA. Regulatory aspects of quality of life. In: Mesbah M, et al., eds. Statistical Methods for Quality of Life Studies, Design, Measurement and Analysis. Dordrecht: Kluwer Academic. 2002.

    Google Scholar 

  10. Beitz J, Gneco C, Justice R. Quality-of-life endpoints in cancer clinical trials: The U.S. Food and Drug Administration Perspective. J Natl Cancer Inst Monogr 1996; 20.

    Google Scholar 

  11. Osoba D, Rodrigues G, Myles J, Zee B, Pater J. Interpreting the significance of changes in health-related quality-of-life scores. J Clin Oncol 1998; 16: 139–144.

    PubMed  CAS  Google Scholar 

  12. Jaeschke R, Singer J, Guyatt GH. Measurement of health status: ascertaining the minimal clinically important difference. Control Clin Trial 1989; 10: 407–415.

    Article  CAS  Google Scholar 

  13. Lydick E, Epstein RS. Interpretation of quality of life changes. Quality Life Res 1993; 2: 221–226.

    Article  CAS  Google Scholar 

Download references

Authors

Editor information

Editors and Affiliations

Rights and permissions

Reprints and permissions

Copyright information

© 2004 Humana Press Inc., Totowa, NJ

About this chapter

Cite this chapter

Chiao, J.H., Williams, G., Griebel, D. (2004). Assessing Tumor-Related Symptoms and Health-Related Quality of Life in Cancer Clinical Trials. In: Teicher, B.A., Andrews, P.A. (eds) Anticancer Drug Development Guide. Cancer Drug Discovery and Development. Humana Press, Totowa, NJ. https://doi.org/10.1007/978-1-59259-739-0_21

Download citation

  • DOI: https://doi.org/10.1007/978-1-59259-739-0_21

  • Publisher Name: Humana Press, Totowa, NJ

  • Print ISBN: 978-1-4684-9841-7

  • Online ISBN: 978-1-59259-739-0

  • eBook Packages: Springer Book Archive

Publish with us

Policies and ethics