Abstract
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.
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References
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.
DeMets D, Furberg C, Friedman L. Data Monitoring in Clinical Trials. A Case Studies Approach. New York: Springer; 2006.
Ellenberg SS, Fleming TR, DeMets D. Data Monitoring Committees in Clinical Trials. A Practical Perspective. West Sussex: Wiley; 2002.
Friedman L, Furberg C, DeMets D. Fundamentals of Clinical Trials. 3rd ed. New York: Springer; 1998.
Further Guidance on a Data and Safety Monitoring for Phase I and Phase II Trials. http://grants.nih.gov/grants/guide/notice-files?NOT-OD-99038.html. Accessed 6/14, 2007.
Guidelines for NIH Intramural Investigators and Institutional Review Boards on Data and Safety Monitoring. http://ohsr.od.nih.gov/info/pdf/InfoSheet18.pdf. Accessed 6/14, 2007.
Fundamentals of Clinical Research (Power Point Lecture; 2005.
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.
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.
DeMets DL, Pocock SJ, Julian DG. The agonising negative trend in monitoring of clinical trials. Lancet. Dec 4, 1999; 354(9194):1983–1988.
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.
Hulley S, Cummings S, Browner Wea. Designing Clinical Research. 2nd ed. Philidelphia, PA: Lippincott Williams & Wilkins; 2000.
Haybittle JL. Repeated assessment of results in clinical trials of cancer treatment. Br J Radiol. Oct 1971; 44(526):793–797.
Pocock SJ. When to stop a clinical trial. BMJ. July 25, 1992; 305(6847):235–240.
O’Brien PC, Fleming TR. A multiple testing procedure for clinical trials. Biometrics. Sept 1979; 35(3):549–556.
Cornfield J. Sequential trials, sequential analysis and the likelihood principle. Am Stat. 1966; 20:18–23.
Jennison C, Turnbull BW. Group Sequential Methods with Applications to Clinical Trials. Boca Raton, FL: Chapman & Hall; 2000.
Armitage P, McPherson CK, Rowe BC. Repeated significance tests on accumulating data. J Roy St Soc A. 1969; 132:235–244.
McPherson K. The problem of examining accumulating data more than once. New Eng J Med. 1975; 290(501–502).
Caiff RM, Ellenberg SS. Statistical approaches and policies for the operations of data and safety monitoring committees. Am Heart J. 2000; 141:301–305.
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.
National Heart L, and Blood Institute, National Institutes of Health. Monitoring Boards for Data and Safety. http://public.nhibi.nih.gov/ocr/home/GetPolicy.aspx?id=8. Accessed 6/14, 2007.
Responsibilities of OSMBs appointed by the NHLBI. National Heart, Lung and Blood Institute. National Institutes of Health. http://www.nhlbi.nih.gov/funding/policies/dsmb_inst.htm
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Glasser, S.P., Williams, O.D. (2008). Data Safety and Monitoring Boards (DSMBs). In: Glasser, S.P. (eds) Essentials of Clinical Research. Springer, Dordrecht. https://doi.org/10.1007/978-1-4020-8486-7_9
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DOI: https://doi.org/10.1007/978-1-4020-8486-7_9
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