299
Views
8
CrossRef citations to date
0
Altmetric
Original Articles

Practical Recommendations for Regional Consistency Evaluation in Multi-Regional Clinical Trials with Different Endpoints

, &
Pages 50-56 | Received 26 Sep 2016, Accepted 30 Aug 2017, Published online: 26 Mar 2018

References

  • Chen, X. Y., Lu, N., Nair, R., Xu, Y. L., Kang, C. L., Huang, Q., Li, N., and Chen, H. Z. (2012), “Decision Rules and Associated Sample Size Planning for Regional Approval Utilizing Multiregional Clinical Trials,” Journal of Biopharmaceutical Statistics, 22, 1001–1018.
  • Hung, H. M. J., Wang, S. J., and O'Neill, R. T. (2010), “Consideration of Regional Difference in Design and Analysis of Multi-Regional Trials,” Pharmaceutical Statistics, 9, 173–178.
  • Lan, K. K. G., and Pinheiro, J. (2012), “Combined Estimation of Treatment Effects Under a Discrete Random Effects Model,” Statistics in Biosciences, 14, 235–244.
  • Lan, K. K. G., Pinheiro, J., and Chen, F. (2014), “Designing Multiregional Trials Under the Discrete Random Effects Model,” Journal of Biopharmaceutical Statistics, 24, 415–428.
  • Kawai, N., Stein, C., Komiyama, O., and Ii, Y. (2008), “An Approach to Rationalize Partitioning Sample Size into Individual Regions in a Multi-Regional Trial,” Drug Information Journal, 42, 139–147.
  • Ko, F. S., Tsou, H. H., Liu, J. P., and Hsiao, C. F. (2010), “Sample Size Determination for a Specific Region in a Multiregional Trial,” Journal of Biopharmaceutical Statistics, 20, 870–885.
  • Ministry of Health, Labor, and Welfare. (2007), Basic Principles on Global Clinical Trials, Tokyo, Japan: PMDA.
  • Quan, H., Li, M., Shih, W. J., Ouyang, S. P., Chen, J., Zhang, J., and Zhao, P. L. (2012), “Empirical Shrinkage Estimator for Consistency Assessment of Treatment Effects in Multi-Regional Clinical Trials,” Statistics in Medicine, 32, 1691–1706.
  • Quan, H., Zhao, P. L., Zhang, J., Roessner, M., and Aizawa, K. (2010a), “Sample Size Considerations for Japanese Patients in a Multi-Regional Trial Based on MHLW Guidance,” Pharmaceutical Statistics, 9, 100–112.
  • Quan, H., Li, M. Y., Chen, J., Gallo, P., Binkowitz, B., Ibia, E., Tanaka, Y., Ouyang, S. P., Luo, X. L., Li, G., Menjoge, S., Talerico, S., and Ikeda, K. (2010b), “Assessment of Consistency of Treatment Effects in Multiregional Clinical Trials,” Drug Information Journal, 44, 617–632.
  • Uesaka, H. (2009), “Sample Size Allocation to Regions in a Multiregional Clinical Trial,” Journal of Biopharmaceutical Statistics, 19, 580–594.
  • Teng, Z., and Chang, M. (2016), “Optimal Multiregional Clinical Trials,” Chapter 11. Multi-Regional Clinical Trials for Simultaneous Global New Drug Development, Boca Raton, FL: CRC Press.
  • Teng, Z., Chen, Y.F., and Chang, M. (2017), “Unified Additional Requirement in Consideration of Regional Approval for Multiregional Clinical Trials,” Journal of Biopharmaceutical Statistics, 1, 15.
  • Tsou, H. H., Hung, H. M. J, Chen, Y. M., Huang, W. S., Chang, W. J., and Hsiao, C. F. (2012), “Establishing Consistency Across all Regions in a Multi-Regional Clinical Trial,” Pharmaceutical Statistics, 11, 295–299.
  • Tsong, Y., Chang, W. J., Dong, X. Y., and Tsou, H. H. (2012), “Assessment of Regional Treatment Effect in a Multiregional Clinical Trial,” Journal of Biopharmaceutical Statistics, 22, 1019–1036.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.