[1] ICH E9 expert Working Group, ICH harmonized tripartite guideline,
statistical principles for clinical trials, Statistics in Medicine 18
(1999), 1905-1942.
[2] Efficacy Working Party, European Medicines Agency Committee for
Medicinal Products for Human Use (CHMP) guideline on the choice of the
non-inferiority margin, Statistics in Medicine 25 (2006),
1628-1638.
[3] C. J. Adcock, A Bayesian approach to calculating sample sizes for
multinomial sampling, The Statistician 36 (1987), 155-159.
[4] C. J. Adcock, Bayesian approaches to the determination of sample
sizes for binomial and multinomial sampling- some comments on the
paper by Pham-Gia and Turkkan, The Statistician 41 (1992), 399-404.
[5] C. J. Adcock, Sample size determination: A review, The
Statistician 46(2) (1997), 261-283.
[6] D. A. Berry, Bayesian approaches for comparative effectiveness
research, Clinical Trials 9 (2012), 37-47.
[7] K. Chaloner and I. Verdinelli, Bayesian experimental design: A
review, Statistical Science 10(3) (1995), 273-304.
[8] L. Joseph, D. B. Wolfson and R. Berger, Sample size calculations
for binomial proportions via highest posterior density intervals, The
Statistician 44(2) (1995), 143-154.
[9] Y. Kawasaki and E. Miyaoka, A posterior density for the difference
between two binomial proportions and the highest posterior density
credible interval, Journal of the Japan Statistical Society 40(2)
(2010), 265-275.
[10] Y. Kawasaki and E. Miyaoka, A Bayesian non-inferiority test for
two independent binomial proportions, Pharmaceutical Statistics 12(4)
(2013), 201-206.
[11] Y. Kawasaki and H. Yamada, On sample size determination based on
a Bayesian index of superiority for two independent binomial
proportions, Journal of Modern Applied Statistical Methods (2015) (in
press).
[12] J. M. Lachin, Introduction to sample size determination and power
analysis for clinical trials, Controlled Clinical Trials 2 (1981),
93-113.
[13] S. Lemeshow, Jr., D. W. Hosmer, J. Klar and S. K. Lwanga,
Adequacy of Sample Size in Health Studies, Wiley, New York, 1990.
[14] D. V. Lindley, The choice of sample size, The Statistician 46
(1997), 129-138.
[15] C. E. M’Lan, L. Joseph and D. B. Wolfson, Bayesian sample
size determination for binomial proportions, Bayesian Analysis 3(2)
(2008), 269-296.
[16] T. Pham-Gia and N. Turkkan, Sample size determination in Bayesian
analysis, The Statistician 41 (1992), 389-397.
[17] D. J. Spiegelhalter and L. S. Freedman, A predictive approach to
selecting the size of a clinical trial, based on subjective clinical,
Statistics in Medicine 5 (1986), 1-13.
[18] B. G. Zaslavsky, Empirical Bayes models of Poisson clinical
trials and sample size determination, Pharmaceutical Statistics 9
(2009), 133-141.