Abstract
Background
A data monitoring committee (DMC) has special responsibilities for protecting the safety of clinical trial participants. Few guidance documents are available that address the operations and mechanics of establishing, serving on, or reporting to a DMC. This article provides a practical guide to sponsors, institutions, and individuals responsible for, or serving on, a DMC.
Methods
A workgroup of professionals from academia and not-for-profit and commercial organizations that included investigators, statisticians, patient advocates, and ethicists met to define the essential elements of planning, coordinating, and populating a DMC. All members of the group have formed, served on, advised, or worked with DMCs.
Results
The group outlined the objectives and mechanics of running a DMC, including operational and practical considerations, membership characteristics, roles, members’ liability, and indemnification. Further, it delineated the roles and responsibilities of each DMC member.
Conclusions
The group recommended practices for each phase of the DMC process from inception through execution of a clinical trial, with appropriate considerations for confidentiality. The group’s practical guidance should assist in comprehensive oversight of appropriate clinical trials and should help DMC members execute their obligations with greater assurance.
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References
DeMets D, Furberg C, Friedman L. Data Monitoring in Clinical Trials. New York: Springer Verlag; 2006.
Ellenberg S, Fleming T, DeMets D. Data Monitoring Committees in Clinical Trials: A Practical Perspective. Chichester, England: J. Wiley & Sons; 2002.
US Food and Drug Administration. Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees. Silver Spring, MD: US FDA; 2006.
Wittes J. Behind closed doors: The data monitoring board in randomized clinical trials. Statist Med. 1993;12(5–6):419–424.
DeMets D, Fleming T, Rockhold F, et al. Liability issues for data monitoring committee members. Clin Trials. 2004;1(6):525–531.
Wittes J, Schactman M. On independent data monitoring committees in oncology clinical trials. Chin Clin Oncol. 2014;3(3).
US Food and Drug Administration. Safety assessment for investigational new drug application safety reporting; draft guidance for industry; availability. Vol FDA-2015-D-4562-00012015.
Glickman S, McHutchison J, Peterson E, et al. Ethical and scientific implications of the globalization of clinical research. N Engl J Med. 2009;360(8):816–823.
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Bierer, B.E., Li, R., Seltzer, J. et al. Responsibilities of Data Monitoring Committees: Consensus Recommendations. Ther Innov Regul Sci 50, 648–659 (2016). https://doi.org/10.1177/2168479016646812
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DOI: https://doi.org/10.1177/2168479016646812