Skip to main content

Monitoring Committees: Why and How

  • Chapter
Data Monitoring in Clinical Trials

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 79.99
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
Softcover Book
USD 99.99
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

Institutional subscriptions

Preview

Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.

References

  1. The Coronary Drug Project Research Group. 1973. The Coronary Drug Project: Design, methods, and baseline results. Circulation 47(Suppl I): I-1–I-79.

    Google Scholar 

  2. Organization, review and administration of cooperative studies (Greenberg Report): A report from the Heart Special Project Committee to the National Advisory Heart Council, May 1967. 1988. Control Clin Trials 9:137–148.

    Article  Google Scholar 

  3. Canner PL. 1983. Monitoring of the data for evidence of adverse or beneficial effects. In, (Canner PL, ed.): The Coronary Drug Project. Methods and Lessons of a Multicenter Clinical Trial. Control Clin Trials 4:467–483.

    Google Scholar 

  4. FDA Draft Guidance on Data Monitoring Committees: http://www.fda.gov/OHRMS/DOCKETS/98fr/010489gd.pdf

    Google Scholar 

  5. NIH Policy for Data and Safety Monitoring: http://grants.nih.gov/grants/guide/noticefiles/not98-084.html

    Google Scholar 

  6. Ellenberg S, Fleming TR, DeMets DL. Data Monitoring Committees in Clinical Trials: A Practical Perspective. 2002. John Wiley & Sons, New York.

    Book  Google Scholar 

  7. Friedman LM, Furberg CD, DeMets DL. Fundamentals of Clinical Trials, third edition. 1998. Springer-Verlag, New York.

    Google Scholar 

  8. Meinert CL. Clinical Trials: Design, Conduct and Analysis. 1986. Oxford University Press, New York.

    Google Scholar 

  9. Piantadosi S. Clinical Trials: A Methodologic Perspective. 1997. John Wiley & Sons, New York.

    Google Scholar 

  10. Pocock SJ. Clinical Trials: A Practical Approach. 1983, John Wiley & Sons, New York.

    Google Scholar 

  11. Freedman B. 1987. Equipoise and the ethics of clinical research. N Engl J Med 317:141–145.

    Article  Google Scholar 

  12. The World Medical Association. World Medical Association Declaration of Helsinki: Ethical principals for medical research involving human subjects. October 2000 amended version, with 2002 clarification. http://www.wma.net/e/policy/b3.htm.

    Google Scholar 

  13. Canner PL. Monitoring clinical trial data for evidence of adverse or beneficial treatment effects. 1979. In Boissel JP, Klimt CR (eds.): Multicenter Controlled Trials: Principles and Problems. INSERM, Paris.

    Google Scholar 

  14. Rose EA, Moskowitz AJ, Packer M, Sollano JA,Williams DL,Tierney AR, Heitjan DF, Meier P, Ascheim DD, Levitan RG,Weinberg AD, Stevenson LW, Shapiro PA, Lazar RM,Watson JT, Goldstein DJ, Gelijns AC, for the REMATCH Investigators. 1999.The REMATCH trial: rationale, design, and end points. Ann Thorac Surg 67:723–730.

    Article  Google Scholar 

  15. NIH Guidance on Reporting Adverse Events to Institutional Review Boards: http://grants.nih.gov/grants/guide/notice-files/not99-107.html

    Google Scholar 

Download references

Author information

Authors and Affiliations

Authors

Editor information

Editors and Affiliations

Rights and permissions

Reprints and permissions

Copyright information

© 2006 Springer Science+Business Media, Inc.

About this chapter

Cite this chapter

DeMets, D.L., Furberg, C.D., Friedman, L.M. (2006). Monitoring Committees: Why and How. In: DeMets, D.L., Furberg, C.D., Friedman, L.M. (eds) Data Monitoring in Clinical Trials. Springer, New York, NY. https://doi.org/10.1007/0-387-30107-0_1

Download citation

Publish with us

Policies and ethics