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Articles

Continuous endpoints in Bayesian two-stage designs

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Pages 966-977 | Received 05 Dec 2014, Accepted 10 Nov 2015, Published online: 09 Jun 2016

References

  • An, M. W., Mandrekar, S. J., Branda, M. E., Hillman, S. L., Adjei, A. A., Pitot, H. C., Goldberg, R. M., Sargent, D. J. (2011). Comparison of continuous versus categorical tumor measurement-based metrics to predict overall survival in cancer treatment trials. Clinical Cancer Research 17:6592–6599.
  • Arellano-Valle, R. B., Branco, M. D., Genton, M. G. (2006). A unified view on skewed distributions arising from selections. Canadian Journal of Statistics 34:581–601.
  • Azzalini A. (2014). The Skew–Normal and Related Families. IMS Monographs Series. Cambridge, UK: Cambridge University Press.
  • Berger, J. O., Wolpert, R. L. (1988). The likelihood principle: a review, generalizations, and statistical implications. IMS Lecture Notes Monogr. Ser.
  • Brutti, P., De Santis, F., Gubbiotti, S. (2008). Robust Bayesian sample size determination in clinical trials. Statistics Medicine 27:2290–2306.
  • De Santis, F. (2006). Sample size determination for robust Bayesian analysis. Journal of the American Statistical Association 101:278–291.
  • Dhani, N., Tu, D., Sargent, D. J., Seymour, L., Moore, M. J. (2009). Alternate endpoints for screening phase II studies. Clinical Cancer Research 15:1873–1882.
  • Gut, A. (2009). An Intermediate Course in Probability. New York: Springer-Verlag.
  • Karrison, T. G., Maitland, M. L., Stadler, W. M., Ratain, M. J. (2007). Design of phase II cancer trials using a continuous endpoint of change in tumor size: application to a study of sorafenib and erlotinib in non small-cell lung cancer. Journal of National Cancer Institute 99:1455–1461.
  • Lavin, P. T., (1981). An alternative model for the evaluation of antitumor activity. Cancer Clinical Trials 4:451–457.
  • Sambucini, V. (2008). A Bayesian predictive two-stage design for phase II clinical trials. Statistics in Medicine 27:1199–1224.
  • Sahu, S. K., Smith, T. M. F. (2006). A Bayesian method of sample size determination with practical applications. Journal of the Royal Statistical Society A 169:235–253.
  • Simon, R. (1989). Optimal two-stage designs for phase II clinical trials. Control Clinical Trials 10:1–10.
  • Snapinn, S. M., Jiang, Q. (2007). Responder analyses and the assessment of a clinically relevant treatment effect. Trials 8:1–6.
  • Spiegelhalter, D. J., Abrams, K. R., Myles, J. P. (2006). Bayesian Approaches to Clinical Trials and Health-care Evaluation. New York: Wiley.
  • Therasse, P., Arbuck, S. G., Eisenhauer, E. A., Wanders, J., Kaplan, R. S., Rubinstein, L., Verweij, J., Van Glabbeke, M., van Oosterom, A. T., Christian, M. C., Gwyther, S. G. (2000). New guidelines to evaluate the response to treatment in solid tumors. Journal of National Cancer Institute 92:205–216.
  • Wang, F., Gelfand, A. E. (2002). A simulation-based approach to Bayesian sample size determination for performance under a given model and for separating models. Statistics Science 17:193–208.
  • Whitehead, J., Valdes-Marquez, E., Lissmats, A. (2009). A simple two-stage design for quantitative responses with application to a study in diabetic neuropathic pain. Pharmaceutical Statistics 8:125–135.
  • Wason, J. M. S., Mander, A. P., Eisen, T. G. (2011). Reducing the sample sizes in two-stage phase II cancer trials by using continuous endpoints. European Journal of Cancer 47:983–989.
  • Wason, J. M., Mander, A. P. (2012). Minimizing the maximum expected sample size in two-stage Phase II clinical trials with continuous outcomes. Journal Biopharmaceutical Statistics 22:836–852.
  • Wason, J. M., Mander, A. P., Thompson, S. G. (2012). Optimal multistage designs for randomised clinical trials with continuous outcomes. Statistics Medicine 31:301–312.

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