REFERENCES
- DeMets , D. L. , Furberg , C. D. , Friedman , L. M. ( 2006 ). Data Monitoring in Clinical Trials: A Case Studies Approach . New York : Springer .
- Ellenberg , S. S. , Fleming , T. R. , DeMets , D. L. ( 2002 ). Data Monitoring Committees in Clinical Trials: A Practical Perspective . New York : John Wiley & Sons .
- Fontanarosa , P. B. , Flanagin , A. , DeAngelis , C. D. ( 2005 ). Reporting conflicts of interest, financial aspects of research and role of sponsors in funded studies . Journal of the American Medical Asociation 294 : 110 – 111 .
- Food and Drug Administration . ( 2006 ). Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees. CBER/CDER/CDRH, U.S. Food and Drug Administration, Rockville, MD .
- Food and Drug Administration . ( 2010 ). Guidance for Industry. Adaptive Design Clinical Trials for Drugs and Biologics. CBER/CDER/CDRH, The United States Food and Drug Administration, Rockville, MD .
- Hemmings , R. , Day , S. ( 2004 ). Regulatory perspectives on data safety monitoring boards: protecting the integrity of data . Drug Safety 27 ( 1 ): 1 – 6 .
- Herson , J. (2009). Data and Safety Monitoring Committees in Clinical Trials . New York : Chapman and Hall/CRC Press, Taylor & Francis.
- International Conference on Harmonisation . ( 1995 ). Guideline for Structure and Content of Clinical Study Report. International Conference on Harmonization, Yokohama, Japan .
- International Conference on Harmonisation. (1996). E6 Good Clinical Practice. Tripartite International Conference on Harmonization Guideline. http://www/ich.org/LOB/ media/MEDIA482.pdf
- International Conference on Harmonisation. (1998). E9 Guideline for Statistical Principles for Clinical Trials. Tripartite International Conference on Harmonization Guideline. http://www/ich.org/LOB/media/MEDIA485.pdf
- National Institutes of Health . ( 1998 ). NIH Policy for Data and Safety Monitoring. National Institutes of Health. June. http://grants1.nih.gov/grants/guide/notice-files/not98-084.html .
- National Institutes of Health . ( 2000 ). Further Guidance On Data and Safety Monitoring for Phase I and II Trials. National Institutes of Health, OD-00-038, June .
- Simon , R. ( 1989 ). Optimal two-stage designs for phase II clinical trials . Controlled Clinical Trials 10 ( 1 ): 1 – 10 .