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Communications in Statistics - Theory and Methods Volume 47, 2018 - Issue 22
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Articles

Two-stage phase II trials with early stopping for effectiveness and safety as well as ineffectiveness or harm

Shixin LiSchool of Mathematical Science, South China Normal University, Guangzhou, PRC
,
Hua JinSchool of Mathematical Science, South China Normal University, Guangzhou, PRCCorrespondence[email protected]
&
Wanyi ChenCollege of Economics, Jinan University, Guangzhou, PRC
Pages 5626-5638 | Received 16 Sep 2016, Accepted 30 Oct 2017, Published online: 06 Dec 2017

References

  • Bryant, J., and R. Day. 1995. Incorporating toxicity considerations into the design of two-stage phase II clinical trials. Biometrics 51:1372–83.
  • Chen, K., and M. Shan. 2008. Optimal and minimax three-stage designs for phase II oncology clinical trials. Contemporary Clinical Trials 29:32–41. doi:10.1016/j.cct.2007.04.008.
  • Chen, T. T. 1997. Optimal three-stage designs for phase II cancer clinical trials. Statistics in Medicine 16 (23):2701–11. doi:10.1002/(ISSN)1097-0258.
  • Conaway, M. R., and G. R. Petroni. 1995. Bivariate sequential designs for phase II trials. Biometrics 51:656–64.
  • Conaway, M. R., and G. R. Petroni. 1996. Designs for phase II trials allowing for a trade-off between response and toxicity. Biometrics 52:1375–86.
  • Fleming, T. R. 1982. One-sample multiple testing procedure for phase II clinical trials. Biometrics 38:143–51. doi:10.2307/2530297.
  • Jin, H. 2007. Alternative designs of phase II trials considering response and toxicity. Contemporary Clinical Trials 28:525–31.
  • Jung, S.-H. 2008. Randomized phase II trials with a prospective control. Statistics in Medicine 27:568–83. doi:10.1002/(ISSN)1097-0258.
  • Lee, J. J., and D. D. Liu. 2008. A predictive probability design for phase II cancer clinical trials. Clinical Trials 5 (2):93–106. doi:10.1177/1740774508089279.
  • Letierce, A., P. Tubert-Bitter, A. Kramar, and J. Maccario. 2003. Two-treatment comparison based on joint toxicity and efficacy ordered alternatives in cancer trials. Statistics in Medicine 22:859–68.
  • Mander, A. P., and S. G. Thompson. 2010. Two-stage designs optimal under the alternative hypothesis for phase II cancer clinical trials. Contemporary Clinical Trials 31:572–78. doi:10.1016/j.cct.2010.07.008.
  • Mander, A. P., J. M. S. Wason, M. J. Sweeting, and S. G. Thompson. 2012. Admissible two-stage designs for phase II cancer clinical trials that incorporate the expected sample size under the alternative hypothesis. Pharmaceutical Statistics 11:91–96. doi:10.1002/pst.501.
  • Meinert, C. L. 1986. Clinical trials: Design, conduct, and analysis. New York: Oxford University Press.
  • Simon, R. 1989. Optimal two-stage designs for phase II clinical trials. Controlled Clinical Trials 10:1–10. doi:10.1016/0197-2456(89)90015-9.
  • Storer, B. E. 1989. Design and analysis of phase I clinical trials. Biometrics 45:925–37.
  • Tournoux, C., Y. De Rycke, J. Medioni, and B. Asselain. 2007. Methods of joint evaluation of efficacy and toxicity in phase II clinical trials. Contemporary Clinical Trials 28 (4):514–24.
  • Wason, J. M. S., and T. Jaki. 2012. Optimal design of multi-arm multi-stage trials. Statistics in Medicine 31:4269–79.
  • Wason, J. M. S., and A. P. Mander. 2012. Minimising the maximum expected sample size in two-stage phase II clinical trials with continuous outcomes. Journal of Biopharmaceutical Statistics 22 (4):836–52.
  • Wason, J. M. S., A. P. Mander, and S. G. Thompson. 2012. Optimal multistage designs for randomized clinical trials with continuous outcomes. Statistics in Medicine 31:301–12.

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