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Articles

Regional efficacy assessment in multiregional clinical development

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Pages 673-682 | Received 22 Jul 2015, Accepted 22 May 2016, Published online: 21 Jul 2016

References

  • China Food and Drug Administration. (2015). Guidance for International Multicenter Clinical Trials (IMCT). Beijing, China.
  • Carroll, K. J., Le Maulf, F. (2011). Japanese guideline on global clinical trials: Statistical implications and alternative criteria for assessing consistency. Drug Information Journal 45:657–667.
  • Chen, J., Quan, H., Binkowitz, B., Ouyang, S. P., Tanaka, Y., Li, G., Menjoge, S., Ibia, E. (2010). Assessing consistent treatment effect in a multi-regional clinical trial: A systematic review. Pharmaceutical Statistics 9:242–253.
  • Chen, C. T., Hung, H. M., Hsiao, C. F. (2012). Design and evaluation of multiregional trials with heterogeneous treatment effect across regions. Journal of Biopharmaceutical Statistics 22(5):1037–1050.
  • Huang, Q., Chen, G., Yuan, Z., Lan, K. K. G. (2012). Design and sample size considerations for simultaneous global drug development program. Journal of Biopharmaceutical Statistics 22(5):1060–1073
  • Kawai, N., Chuang-Stein, C., Komiyama, O., Ii, Y. (2008) An approach to rationalize partitioning sample size into individual regions in a multiregional trial. Drug Information Journal 42:139–147.
  • Ko, F. S., Tsou, H. H., Liu, J. P., Hsiao, C. F. (2010). Sample size determination for a specific region in a multiregional trial. Journal of Biopharmaceutical Statistics 20(4):870–885.
  • Li, N., Wang, W. (2012). Commentary: Practical and statistical considerations on simultaneous global drug development. Journal of Biopharmaceutical Statistics 22(5):1074–1077.
  • Ministry of Health, Labor, and Welfare. (2007). Basic Principles on Global Clinical Trials. Tokyo, Japan.
  • Quan, H., Zhao, P. L., Zhang, J., Roessner, M., Aizawa, K. (2010). Sample size considerations for Japanese patients in a multi-regional trial based on MHLW guidance. Pharmaceutical Statistics 9(1):100–112.
  • Quan, H., Mao, X., Chen, J., Shih, W. J., Ouyang, S. P, Zhang, J., Zhao, P-L, Binkowitz, B. (2014). Multi-regional clinical trial design and consistency assessment of treatment effects, Statistics in Medicine 33(13):2191–2205.
  • Tsou, H. H., Chien, T. Y., Liu, J. P., Hsiao, C. F. (2011). A consistency approach to evaluation of bridging studies and multi-regional trials. Statistics in Medicine 30(17):2171–2186.
  • Tsong, Y., Chang, W. J., Dong, X., Tsou, H. H. (2012). Assessment of regional treatment effect in a multiregional clinical trial. Journal of Biopharmaceutical Statistics 22(5):1019–1036.
  • Uesaka, H. (2009). Sample size allocation to regions in a multiregional trial. Journal of Biopharmaceutical Statistics 19:580–594.

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