PRINT

References:

Broklehurst, P., Elbourne, D., & Alfirevic, Z. (2000). Role of external evidence in monitoring clinical trials: experience from a perinatal trial. BMJ (320), 995-998.

DAMOCLES Study Group. (2005). A proposed charter for clinical trial data monitoring committees: helping them to do their job well. The Lancet, 365, 711-722.

DeMets, D. L., & Califf, R. M. (2002). Lessons Learned from recent cardiovascular clinical trials: Part II. Circulation, 106, 746-751.

DeMets, D. L., Furberg, C. D., & Friedman, L.M. (Eds). (2006). Data Monitoring in clinical trials: A case studies approach. New York, NY: Springer Science & Business Media, Inc.

(US) Food and Drug Administration. (2006). Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees. Federal Register: March 28, 2006, 71 (59). Docket No. 2001D-0489.

Ellenberg, S. S., Fleming, R. R., DeMets, D. L. (2003). Data monitoring committees in clinical trials: A practical perspective. England, UK: John Wiley & Sons.

Fleming, T. R., Ellenberg, S, DeMets, D. L. (2002). Monitoring clinical trials: Issues and controversies regarding confidentiality. Statistics in Medicine, 21: 2843-2851.

Freemantle, N. & Stocken, D. (2004). The commercialization of clinical research: who pays the piper, calls the tune? Family Practice, 21: 335-336.

Gordon, V. M., Sugarman, J., Kass, N. (1998). Toward a more comprehensive approach to protecting human subjects: the interface of data safety monitoring boards and institutional review boards in randomized clinical trials. IRB: A Review of Human Subjects Research, 20 (1), 1-5.

Hampton, J. R. (2000). Personal paper: Clinical trial safety committees: the devil's spoon. BMJ, 320, 244-245.

Meinert, C. L. (1998). Clinical trials and treatment effects monitoring. Controlled Clinical Trials 19, 515-522.

National Institutes of Health. (1979). NIH Guide for Grants and Contracts 8 (8), June 5, 1979: Clinical Trial Activity, p. 29.

National Institutes of Health. (1998). NIH Policy for Data and Safety Monitoring, June 10, 1998.

National Institutes of Health. (1999). Guidance on reporting adverse events to institutional review boards for NIH-supported multicenter clinical trials, June 11, 1999.

National Institutes of Health. (2000). Further guidance on a data and safety monitoring for phase I and phase II trials, June 6, 2000.

Wittes. J. (2004). Forming your phase III trial’s data and safety monitoring board: A perspective on safety. Journal of Investigative Medicine, 52 (7), 453-458.

Whitehead, J. (1999). On being the statistician on a data and safety monitoring board. Statistics in Medicine, 18, 342-3434.

World Health Organization. (2005). Operational guidelines for the establishment and functioning of data and safety monitoring boards.

Close Window