Data Safety and Monitoring Boards (DSMBs)

  • Stephen P. Glasser
  • O. Dale Williams


Data Safety and Monitoring Boards were introduced as a mechanism for monitoring interim data in clinical trials as a way to ensure the safety of participating subjects. Procedures for and experience with DSMBs has expanded considerably over recent years and they are now required by the NIH for almost any interventional and for some observational trials. A DSMB’s primary role is to evaluate adverse events and to determine the relationship of the adverse event to the therapy (or device). Interim analyses and early termination of studies are two aspects of DSMBs that are particularly difficult. This chapter will discuss the role of DSMBs and address the aforementioned issues.


Interim Analysis Data Safety Data Monitoring Committee Monitoring Board Interim Data 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.


Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.


  1. 1.
    Heart Special Project Committee. Organization, Review, and Administration of Cooperative Studies. Greenberg Report: A Report from Heart Special Project Committee to the National Advisory Heart Council. Control Clin Trials. 1967; 9:137–148.Google Scholar
  2. 2.
    DeMets D, Furberg C, Friedman L. Data Monitoring in Clinical Trials. A Case Studies Approach. New York: Springer; 2006.Google Scholar
  3. 3.
    Ellenberg SS, Fleming TR, DeMets D. Data Monitoring Committees in Clinical Trials. A Practical Perspective. West Sussex: Wiley; 2002.CrossRefGoogle Scholar
  4. 4.
    Friedman L, Furberg C, DeMets D. Fundamentals of Clinical Trials. 3rd ed. New York: Springer; 1998.Google Scholar
  5. 5.
    Further Guidance on a Data and Safety Monitoring for Phase I and Phase II Trials. Accessed 6/14, 2007.
  6. 6.
    Guidelines for NIH Intramural Investigators and Institutional Review Boards on Data and Safety Monitoring. Accessed 6/14, 2007.
  7. 7.
    Fundamentals of Clinical Research (Power Point Lecture; 2005.Google Scholar
  8. 8.
    The Coronary Drug Project Research Group. Practical aspects of decision making in clinical trials: the coronary drug project as a case study. Control Clin Trials. May 1981; 1(4):363–376.CrossRefGoogle Scholar
  9. 9.
    DeMets DL, Lan KK. Interim analysis: the alpha spending function approach. Stat Med. July 15–30, 1994; 13(13–14):1341–1352; discussion 1353–1346.PubMedCrossRefGoogle Scholar
  10. 10.
    DeMets DL, Pocock SJ, Julian DG. The agonising negative trend in monitoring of clinical trials. Lancet. Dec 4, 1999; 354(9194):1983–1988.PubMedCrossRefGoogle Scholar
  11. 11.
    Peto R, Pike MC, Armitage P, et al. Design and analysis of randomized clinical trials requiring prolonged observation of each patient. I. Introduction and design. Br J Cancer. Dec 1976; 34(6):585–612.PubMedGoogle Scholar
  12. 12.
    Hulley S, Cummings S, Browner Wea. Designing Clinical Research. 2nd ed. Philidelphia, PA: Lippincott Williams & Wilkins; 2000.Google Scholar
  13. 13.
    Haybittle JL. Repeated assessment of results in clinical trials of cancer treatment. Br J Radiol. Oct 1971; 44(526):793–797.PubMedCrossRefGoogle Scholar
  14. 14.
    Pocock SJ. When to stop a clinical trial. BMJ. July 25, 1992; 305(6847):235–240.PubMedCrossRefGoogle Scholar
  15. 15.
    O’Brien PC, Fleming TR. A multiple testing procedure for clinical trials. Biometrics. Sept 1979; 35(3):549–556.PubMedCrossRefGoogle Scholar
  16. 16.
    Cornfield J. Sequential trials, sequential analysis and the likelihood principle. Am Stat. 1966; 20:18–23.CrossRefGoogle Scholar
  17. 17.
    Jennison C, Turnbull BW. Group Sequential Methods with Applications to Clinical Trials. Boca Raton, FL: Chapman & Hall; 2000.Google Scholar
  18. 18.
    Armitage P, McPherson CK, Rowe BC. Repeated significance tests on accumulating data. J Roy St Soc A. 1969; 132:235–244.CrossRefGoogle Scholar
  19. 19.
    McPherson K. The problem of examining accumulating data more than once. New Eng J Med. 1975; 290(501–502).Google Scholar
  20. 20.
    Caiff RM, Ellenberg SS. Statistical approaches and policies for the operations of data and safety monitoring committees. Am Heart J. 2000; 141:301–305.Google Scholar
  21. 21.
    Montori VM, Devereaux PJ, Adhikari NK, et al. Randomized trials stopped early for benefit: a systematic review. JAMA. Nov 2, 2005; 294(17):2203–2209.PubMedCrossRefGoogle Scholar
  22. 22.
    National Heart L, and Blood Institute, National Institutes of Health. Monitoring Boards for Data and Safety. Accessed 6/14, 2007.
  23. 23.
    Responsibilities of OSMBs appointed by the NHLBI. National Heart, Lung and Blood Institute. National Institutes of Health.

Copyright information

© Springer Science + Business Media B.V 2008

Authors and Affiliations

  • Stephen P. Glasser
    • 1
  • O. Dale Williams
    • 2
  1. 1.Univesity of Alabama at Birmingham, Birmingham, AlabamaBirmingham
  2. 2.Division of Preventive MedicineUnivesity of Alabama at BirminghamBirmingham

Personalised recommendations