References
- Chang, M. 2016. Adaptive design theory and implementation using SAS and R. 2nd ed. New York: Chapman and Hall/CRC Press.
- Chow, S. C. 2019. Statistical considerations for rare disease drug development. Journal of Biopharmaceutical Statistics, to Appear.
- Chow, S. C., and M. Chang. 2011. Adaptive design methods in clinical trials. 2nd ed. New York: Chapman and Hall/CRC Press.
- Chow, S. C., J. Shao, H. Wang, and Y. Lokhnygina. 2017. Sample size calculations in clinical research. 3rd ed. New York: Chapman and Hall/CRC Press.
- FDA. 2015. Guidance for industry - rare diseases: common issues in drug development. Silver Spring, Maryland: Center for Drug Evaluation and Research, the U.S. Food and Drug Administration.
- Lilford, R. J., J. G. Thornton, and D. Braunholtz. 1995. Clinical trials and rare diseases: a way out of a conundrum. BMJ 311 (7020):1621–1625.
- Shao, J., and S. C. Chow. 2002. Reproducibility probability in clinical trials. Statistics in Medicine 21 (12):1727–1742.