Sage Journals: Discover world-class research

Abstract

Background

A major goal of the National Institutes of Health’s Clinical and Translational Science Award program is to facilitate clinical research and enhance the transition of basic to clinical research. As such, a number of Clinical and Translational Science Award centers have developed services to facilitate the conduct of clinical research, including support with fulfilling regulatory requirements.

Methods

The University of Kentucky sought to establish an institutional semi-independent monitoring committee to provide oversight for clinical research studies per National Institutes of Health requirements and recommendations. Our semi-independent monitoring committee was initiated in 2010.

Results

Since the inception of our semi-independent monitoring committee we have restructured its operations and protocols to improve efficiency. This article discusses our experiences with semi-independent monitoring committee creation and growth.

Conclusion

This article summarizes our experience in creating and maturing an institutional data monitoring committee.

Keywords

Data safety monitoring institutional data monitoring committee leadership membership clinical trials

Get full access to this article

View all access options for this article.

References

Hicks

Laupacis

Slutsky

AS.

A primer on data safety monitoring boards: mission, methods, and controversies. Intensive Care Med 2007; 33(10): 1815–1818.

Mondoro

TH.

Data safety monitoring boards: a word from a sponsor (NHLBI). Transfusion 2009; 49(8): 1537–1539.

Neaton

Grund

Wentworth

How to construct an optimal interim report: what the data monitoring committee does and doesn’t need to know. Clin Trials 2018; 15(4): 359–365.

Fleming

DeMets

Roe

, et al. Data monitoring committees: promoting best practices to address emerging challenges. Clin Trials 2017; 14(2): 115–123.

Grant

Altman

Babiker

, et al. Issues in data monitoring and interim analysis of trials. Health Technol Assess 2005; 9(7): 1–238, iii–iv.

Borg Debono

Mbuagbaw

Thabane

. Sharing interim trial results by the Data Safety Monitoring Board with those responsible for the trial’s conduct and progress: a narrative review. Trials 2017; 18(1): 120.

Bloudoff-Indelicato

Threat of interim data leaks prompts call for international rules. Nat Med 2015; 21(3): 200.

Office of Communication, Training and Manufacturers Assistance (CBER). Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees. 2006. Food and Drug Administration, Rockville, MD. Accessed from http://www.fda.gov/cder/guidance/index.htm on 12 February 2019.

Buhr

Downs

Rhorer

, et al. Reports to independent data monitoring committees: an appeal for clarity, completeness, and comprehensibility. Ther Innov Regul Sci 2018; 52(4): 459–468.

10.

DeMets

Furberg

Friedman

LM.

Data monitoring in clinical trials: a case studies approach. New York: Springer Science+Business Media, 2006.

11.

Ellenberg

Fleming

DeMets

DL.

Data monitoring committees in clinical trials: a practical perspective. West Sussex: John Wiley & Sons, Ltd., 2002.

12.

Herson

Data and safety monitoring committees in clinical trials. London: Chapman & Hall, 2016.

13.

DeMets

Fleming

Rockhold

, et al. Liability issues for data monitoring committee members. Clin Trials 2004; 1(6): 525–531.

14.

Fleming

Ellenberg

DeMets

DL.

Data monitoring committees: current issues. Clin Trials 2018; 15: 321–328.

15.

Eckstein

Building a more connected DSMB: better integrating ethics review and safety monitoring. Account Res 2015; 22(2): 81–105.

16.

Tereskerz

PM.

Data safety monitoring boards: legal and ethical considerations for research accountability. Account Res 2010; 17(1): 30–50.

Creation of an institutional semi-independent data monitoring committee

Abstract

Background

Methods

Results

Conclusion

Keywords

Get full access to this article

References