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 challenges. This chapter will discuss the role of DSMBs and address the aforementioned issues.
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References
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;9:137–48.
DeMets D, Furberg C, Friedman L. Data monitoring in clinical trials. A case studies approach. New York: Springer; 2006.
Ellenberg SS, Fleming TR. 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.
Connolly SJ. Use and misuse of surrogate outcomes in arrhythmia trials. Circulation. 2006;113:764–6.
NIH policy and guidelines on the inclusion of women and minorities as subjects in clinical research. http://grants1.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. Accessed 16 July 2013
Schulz KF, Grimes DA. Unequal group sizes in randomised trials: guarding against guessing. Lancet. 2002;359:966–70.
Williams OD. Fundamentals of clinical research (Power Point Lecture). 2005.
Practical aspects of decision making in clinical trials: the coronary drug project as a case study. The Coronary Drug Project Research Group. Control Clin Trials 1981;1:363–76.
DeMets DL, Lan KK. Interim analysis: the alpha spending function approach. Stat Med. 1994;13:1341–52; discussion 53–6.
DeMets DL, Pocock SJ, Julian DG. The agonising negative trend in monitoring of clinical trials. Lancet. 1999;354:1983–8.
Peto R, Pike MC, Armitage P, Breslow NE, Cox DR, Howard SV, et al. Design and analysis of randomized clinical trials requiring prolonged observation of each patient. I. Introduction and design. Br J Cancer. 1976;34:585–612. PMC2025229.
Hulley S, Cummings S, Browner W. Designing clinical research. 2nd ed. Philadelphia: Lippincott Williams & Wilkins; 2000.
Haybittle JL. Repeated assessment of results in clinical trials of cancer treatment. Br J Radiol. 1971;44:793–7.
Pocock SJ. When to stop a clinical trial. BMJ. 1992;305:235–40.
O’Brien PC, Fleming TR. A multiple testing procedure for clinical trials. Biometrics. 1979;35:549–56.
Cornfield J. Sequential trials, sequential analysis and the likelihood principle. Am Stat. 1966;20:18–23. doi:10.1080/00031305.1966.10479786.
Jennison C, Turnbull BW. Group sequential methods with applications to clinical trials. Boca Raton: Chapman and Hall; 2000.
Armitage P, McPherson CK, Rowe BC. Repeated significance tests on accumulating data. J R Stat Soc Ser A Stat Soc. 1969;132:235–44.
McPherson K. The problem of examining accumulating data more than once. N Engl J Med. 1974;290:501–2.
Caiff RM, Ellenberg SS. Statistical approaches and policies for the operations of Data and Safety Monitoring Committees. Am Heart J. 2000;141:301–5.
Montori VM, Devereaux PJ, Adhikari NK, Burns KE, Eggert CH, Briel M, et al. Randomized trials stopped early for benefit: a systematic review. JAMA. 2005;294:2203–9.
Monitoring Boards for Data and Safety. http://public.nhibi.nih.gov/ocr/home/GetPolicy.aspx?id=8. Accessed 14 June 2007.
Tharmananathan P, Calvert M, Hampton J, Freemantle N. The use of interim data and data monitoring committee recommendations in randomized controlled trial reports: frequency, implications and potential sources of bias. BMC Med Res Methodol. 2008;8:12.
Probstfield JL, Frye RL. Strategies for recruitment and retention of participants in clinical trials. JAMA. 2011;306:1798–9. doi:10.1001/jama.2011.1544.
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Glasser, S.P., Williams, O.D. (2014). Data Safety and Monitoring Boards (DSMBs). In: Glasser, S. (eds) Essentials of Clinical Research. Springer, Cham. https://doi.org/10.1007/978-3-319-05470-4_9
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DOI: https://doi.org/10.1007/978-3-319-05470-4_9
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