Skip to main content
SpringerLink
Log in
Book cover

Perugia Consensus Conference on Antiemetic Therapy pp 113–120Cite as

Statistical Considerations in the Design, Conduct, and Analysis of Antiemetic Clinical Trials

An Emerging Consensus

  • Conference paper

  • 43 Accesses

Abstract

Various aspects of trial design and planning for clinical testing of antiemetic therapies administered to cancer patients are considered. It is generally felt that a randomized double-blind parallel-arm design is the best. Ways of achieving adequate power of such studies are discussed briefly, as is the need for previous identification of primary and secondary end points. Finally, summary recommendations are given.

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

Chapter
USD   29.95
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
eBook
USD   84.99
Price excludes VAT (USA)
  • Available as EPUB and PDF
  • Read on any device
  • Instant download
  • Own it forever
Softcover Book
USD   109.99
Price excludes VAT (USA)
  • Compact, lightweight 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

Learn about institutional subscriptions

Preview

Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.

References

  1. Aapro M (1993) Methodological issues in antiemetic studies. Invest New Drugs 11: 243–253

    Article  PubMed  CAS  Google Scholar 

  2. Armitage PW, McPherson K, Rowe BC (1969) Repeated significance tests on accumulating data. Journal of the Royal Statistical Society A 132: 235–244

    Article  Google Scholar 

  3. Ballatori E, Roila F, Del Favero A (1996) Methodology of antiemetic trials. In: Tonato M (ed) Antiemetics in the supportive care in cancer. Springer, Berlin Heidelberg New York, pp 35–47

    Google Scholar 

  4. Bechhofer RE, Santner TJ, Goldsman DM (1995) Design and analysis of experiments for statistical selection, screening, and multiple comparisons. Wiley, New York

    Google Scholar 

  5. Bergmann JF (1995) Méthodologie de l’évaluation des antiémétiques. Bull Cancer 82: 1062–1066

    PubMed  CAS  Google Scholar 

  6. Blackwelder WC (1982) Proving the null hypothesis in clinical trials. Control Clin Trials 3: 345–353

    Article  PubMed  CAS  Google Scholar 

  7. Bonneterre J, Hecquet B, Adenis A, Fournier C, Pion JM, Demaille A (1991) How do patients and physicians decide which antiemetic is the best in a cross-over study? Proc ASCO 10: 323

    Google Scholar 

  8. Byar DP, Piantadosi S (1985) Factorial designs for randomized clinical trials. Cancer Treat Rep 69: 1055–1063

    PubMed  CAS  Google Scholar 

  9. Geller NL (1987) Planned interim analysis and its role in cancer clinical trials. J Clin Oncol 5: 1857–1490

    Google Scholar 

  10. Gralla RJ, Clark RA, Kris MG, Tyson LB (1991) Methodology in anti-emetic trials. Eur J Cancer 27 [Suppl 1]: S5 - S8

    Article  PubMed  Google Scholar 

  11. Green SJ, Fleming TR, O’Fallon JR (1987) Policies for study monitoring and interim reporting of results. J Clin Oncol 5: 477–1484

    Google Scholar 

  12. Groshen S (1992) Antiemetic study design: a discussion of Dr. Olver’s paper. Br J Cancer 66 [Suppl XIX]: S35 – S37

    Google Scholar 

  13. Italian Group for Antiemetic Research (1997) Delayed emesis induced by moderate emetogenic chemotherapy: do we need to treat all patients? Ann Oncol (in press)

    Google Scholar 

  14. Lee YJ, Ellenberg JH, Hirtz DG, Nelson KB (1991) Analysis of clinical trials by treatment actually received: is it really an option? Stat Med 10: 1595–1605

    Article  PubMed  CAS  Google Scholar 

  15. Lewis JA, Machin D (1993) Intention to treat–who should use ITT? Br J Cancer 68: 647–650

    Article  PubMed  CAS  Google Scholar 

  16. Makuch R, Simon R (1978) Sample size requirements for evaluating a conservative therapy. Cancer Treat Rep 62: 1037–1040

    PubMed  CAS  Google Scholar 

  17. Morrow GR (1992) Methodology and assessment in clinical anti-emetic research: a meta-analysis of outcome parameters. Br J Cancer 66 [Suppl XIX1: S38 - S41

    Google Scholar 

  18. Morrow GR, Roscoe JA (1997) Anticipatory nausea and vomiting: models, mechanisms and management. In: Dicato M (ed) Medical Management of Cancer-Treatment Induced Emesis. Martin Dunitz, London, pp 149–166

    Google Scholar 

  19. Olver IN (1992) Antiemetic study design: desirable objectives, stratifications and analyses. Br J Cancer 66 [Suppl XIX]: S30 - S34

    Google Scholar 

  20. Olver IN (1996) Antiemetic study methodology: recommendations for future studies. Oncology 53 [Suppl 1]: 96–101

    Article  PubMed  Google Scholar 

  21. Olver IN, Simon RM, Aisner J (1986) Antiemetic studies: a methodological discussion. Cancer Treat Rep 70: 555–563

    PubMed  CAS  Google Scholar 

  22. Olver IN, Matthews JP, Bishop JF, Smith RA (1994) The roles of patient and observer assessments in anti-emetic trials. Eur J Cancer [A] 30: 1223–1227

    Article  Google Scholar 

  23. Seipp CA, Chang AE, Shiling DJ, Rosenberg SA (1980) In search of an effective antiemetic: a nursing staff participates in marijuana research. Cancer Nurs 21: 271–276

    Article  Google Scholar 

  24. Zelen M (1987) Early stopping, interim analyses, and monitoring committees: what are the tradeoffs? J Clin Oncol 5: 1314–1315

    PubMed  CAS  Google Scholar 

Download references

Authors
  1. Gary R. Morrow
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Enzo Ballatori
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Susan Groshen
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Ian Olver
    View author publications

    You can also search for this author in PubMed Google Scholar

Editor information

Editors and Affiliations

  1. Ochsner Cancer Institute, 1514 Jefferson Highway, 70121-2483, New Orleans, LA, USA

    Richard J. Gralla

  2. Oncologia Medica, Policlinico Monteluce, Via Brunamonti, 06122, Perugia, Italy

    Maurizio Tonato  & Fausto Roila  & 

Rights and permissions

Reprints and permissions

Copyright information

© 1998 Springer-Verlag Berlin Heidelberg

About this paper

Cite this paper

Morrow, G.R., Ballatori, E., Groshen, S., Olver, I. (1998). Statistical Considerations in the Design, Conduct, and Analysis of Antiemetic Clinical Trials. In: Gralla, R.J., Tonato, M., Roila, F. (eds) Perugia Consensus Conference on Antiemetic Therapy. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-72137-3_10

Download citation

  • DOI: https://doi.org/10.1007/978-3-642-72137-3_10

  • Publisher Name: Springer, Berlin, Heidelberg

  • Print ISBN: 978-3-642-72139-7

  • Online ISBN: 978-3-642-72137-3

  • eBook Packages: Springer Book Archive

Publish with us

Policies and ethics

Search

Navigation