Skip to main content

Part of the book series: Foundations of Neurology ((FONY,volume 1))

  • 105 Accesses

Abstract

In the second half of the twentieth century, through their pioneering work in clinical trial and statistical methodology, individuals such as Sir A.B. Hill in the United Kingdom and J. Cornfield in the United States ushered in the randomized controlled clinical trial, a major advance in clinical medicine. Clearly, however, the comparative clinical experiment dates from much earlier; the Book of Daniel describes a comparative trial of two diets [2]. Several authors have reviewed the development of the modern clinical investigation from a statistical viewpoint [3, 4].

It is important to understand what you CAN DO before you learn to measure how WELL you seem to have DONE it. Tukey [1]

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 259.00
Price excludes VAT (USA)
  • Available as EPUB and PDF
  • Read on any device
  • Instant download
  • Own it forever
Softcover Book
USD 329.99
Price excludes VAT (USA)
  • Compact, lightweight edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info
Hardcover Book
USD 329.99
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. Tukey JW (1977) Exploratory Data Analysis. Reading, MA: Addison-Welscy.

    Google Scholar 

  2. Daniel I: verse 1–15.

    Google Scholar 

  3. Bull JP (1959) The historical development of clinical therapeutic trials. J Chronic Dis 10:218–248.

    Article  PubMed  CAS  Google Scholar 

  4. Pollock AV (1983). Review article: Controlled clinical trials. Life Support Sys 1:227–234.

    CAS  Google Scholar 

  5. Fredrickson DS (1968). The field trial: Some thoughts on the indispensable ordeal. Bull NY Acad Med 44:985–993.

    CAS  Google Scholar 

  6. White BG (1982). Testing antiepileptic drugs in humans: Statistical considerations. In Woodbury DM, Penry JK, Pippenger CE (eds.), Antiepileptic Drugs. New York: Raven Press, pp. 159–166.

    Google Scholar 

  7. Bloomfield P (1976). Fourier Analysis of Time Series: An Introduction. New York: Wiley.

    Google Scholar 

  8. Spilker B (1984). Guide to Clinical Studies and Developing Protocols. New York: Raven Press.

    Google Scholar 

  9. Meincert CL (1986). Clinical Trials — Design, Conduct, and Analysis. New York: Oxford University Press.

    Google Scholar 

  10. Fleiss JL (1986). The Design and Analysis of Clinical Experiments. New York: Wiley.

    Google Scholar 

  11. Friedman LM, Furberg CD, DeMets DL (1985) Fundamentals of Clinical Trials, 2nd edition. Boston, MA: PSG.

    Google Scholar 

  12. Tukey J (1977). Some thoughts on clinical trials, especially problems of multiplicity. Science 198:679–684.

    Article  PubMed  CAS  Google Scholar 

  13. Byar DP, Simon RM, et al. (1976). Randomized clinical trials: perspectives on some recent ideas. N Engl J Med 295:74–80.

    Article  PubMed  CAS  Google Scholar 

  14. Ingelfinger FJ (1972). The randomized clinical trial (editorial). N Engl J Med 287:100–101.

    Article  PubMed  CAS  Google Scholar 

  15. Efron B (1971). Forcing a sequential experiment to be balanced. Biometrika 58:403–417.

    Article  Google Scholar 

  16. Zelen M (1979). A new design for randomized clinical trials. N Engl J Med, 300:1242–1245.

    Article  PubMed  CAS  Google Scholar 

  17. Fleiss JL (1973). Statistical Methods for Rates and Proportions. New York: Wiley.

    Google Scholar 

  18. Lachin JM (1981). An introduction to sample size determination and power analysis for clinical trials. Controlled Clin Trials 2:93–113.

    Article  PubMed  CAS  Google Scholar 

  19. Brown BW, Hollander M (1977). Statistics — A Biomedical Introduction. New York: Wiley.

    Google Scholar 

  20. Lachin J (1982). Statistical inference in clinical trials. In: Tygstrup N, Lachin JM, Juhl E (eds.), The Randomized Clinical Trials and Therapeutic Decisions. New York: Marcel Dekker, pp. 117–144.

    Google Scholar 

  21. Young MJ, Bresnitz EA, Strom BL (1983). Size nomograms for interpreting negative clinical studies. Ann Intern Med 99:248–251.

    PubMed  CAS  Google Scholar 

  22. Blackwelder WC, Chang MC (1984). Sample size graphs for “proving the null hypothesis”. Controlled Clin Trials 5:97–105.

    Article  PubMed  CAS  Google Scholar 

Download references

Authors

Editor information

Editors and Affiliations

Rights and permissions

Reprints and permissions

Copyright information

© 1990 Kluwer Academic Publishers

About this chapter

Cite this chapter

White, B.G. (1990). Initial Statistical Considerations. In: Porter, R.J., Schoenberg, B.S. (eds) Controlled Clinical Trials in Neurological Disease. Foundations of Neurology, vol 1. Springer, Boston, MA. https://doi.org/10.1007/978-1-4613-1495-0_2

Download citation

  • DOI: https://doi.org/10.1007/978-1-4613-1495-0_2

  • Publisher Name: Springer, Boston, MA

  • Print ISBN: 978-1-4612-8804-6

  • Online ISBN: 978-1-4613-1495-0

  • eBook Packages: Springer Book Archive

Publish with us

Policies and ethics