1 |
Chang, M. (2008). Adaptive Design Theory and Implementation Using SAS and R, Chapman & Hall/CRC, New York
|
2 |
CHMP (2005). Guideline on Data Monitoring Committees
|
3 |
CHMP (2006). Reflection paper on methodological issues in confirmatory clinical trials with planned with an adaptive design
|
4 |
Chow, S. C. and Chang, M. (2007). Adaptive Design Methods in Clinical Trials, Chapman & Hall/CRC, New York
|
5 |
Ellenberg, S. S., Fleming, T. R. and DeMets, D. L. (2002). Data Monitoring Committees in Clinical Trials:A Practical Perspective, John Wiley & Sons, New York
|
6 |
ICH E6 (1996). International Conference on Harmonization Tripartite Guideline for Good Clinical Practice
|
7 |
ICH E9 (1998). Note for Guidance on Statistical Principles for Clinical Trials
|
8 |
Wang, S. J. and Hung, J. (2008). Adaptive Designs in Drug Development, ISBS short course note
|