359
Views
2
CrossRef citations to date
0
Altmetric
Articles

Sample size determination with familywise control of both type I and type II errors in clinical trials

&
Pages 951-965 | Received 24 May 2014, Accepted 10 Nov 2015, Published online: 17 May 2016

References

  • Bang, H., Jung, S.-H., George, S. L. (2005). Sample size calculation for simulation-based multiple-testing procedures. Journal of Biopharmaceutical Statistics 15(6):957–967. PMID: 16279354.
  • Berger, R. L. (1982). Multiparameter hypothesis testing and acceptance sampling. Technometrics 24(4):295–300.
  • Chen, J., Luo, J., Liu, K., Mehrotra, D. V. (2011). On power and sample size computation for multiple testing procedures. Computational Statistics & Data Analysis 55(1):110–122.
  • Committee for Proprietary Medicinal Products (CPMP). (2002). Points to consider on multiplicity issues in clinical trials. London: The European Agency for the Evaluation of Medicinal Products.
  • Dunnett, C. W., Horn, M., Vollandt, R. (2001). Sample size determination in step-down and step-up multiple tests for comparing treatments with a control. Journal of Statistical Planning and Inference 97(2):367–384.
  • Dunnett, C. W., Tamhane, A. C. (1991). Step-down multiple tests for comparing treatment with a control in unbalanced one-way layouts. Statistics in Medicine 11:1057–1063.
  • Dunnett, C. W., Tamhane, A. C. (1992). A step-up multiple test procedure. Journal of the American Statistical Association 87(417):162–170.
  • Dunnett, C. W., Tamhane, A. C. (1995). Step-up multiple testing of parameters with unequally correlated estimates. Biometrics 51:217–227.
  • Eaton, M. L., Muirhead, R. J. (2007). On a multiple endpoints testing problem. Journal of Statistical Planning and Inference 137:3416–3429.
  • European Medicines Agency. (2007). Macugen: European Public Assessment Report (EPAR) – Scientific Discussion. Retrieved from http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Scientific_Discussion/human/000620/WC500026218.pdf.
  • Hayter, A. J., Tamhane, A. C. (1991). Sample size determination for step-down multiple test procedures: Orthogonal contrasts and comparisons with a control. Journal of Statistical Planning and Inference 27(3):271–290.
  • Hochberg, Y. (1988). A sharper Bonferroni procedure for multiple tests of significance. Biometrika 75:800–802.
  • Huang, Y., Hsu, J. C. (2007). Hochberg’s step-up method: Cutting corners off Holm’s step-down method. Biometrika 94(4):965–975.
  • Kwong, K. S., Cheung, S. H., Wen, M.-J. (2010). Sample size determination in step-up testing procedures for multiple comparisons with a control. Statistics in Medicine 29(26):2743–2756.
  • Liu, W. (1997). On sample size determination of Dunnett’s procedure for comparing several treatments with a control. Journal of Statistical Planning and Inference 62(2):255–261.
  • Offen, W., Chuang-Stein, C., Dmitrienko, A., Littman, G., Maca, J., Meyerson, L., Muirhead, R., Stryszak, P., Boddy, A., Chen, K., Copley-Merriman, K., Dere, W., Givens, S., Hall, D., Henry, D., Jackson, J. D., Krishen, A., Liu, T., Ryder, S., Sankoh, A., Wang, J., Yeh, C.- H. (2007). Multiple co-primary endpoints: Medical and statistical solutions. A report from the multiple endpoints expert team of the pharmaceutical research and manufacturers of America. Drug Information Journal 41:31–46.
  • Sozu, T., Sugimoto, T., Hamasaki, T. (2010). Sample size determination in clinical trials with multiple co-primary binary endpoints. Statistics in Medicine 29:2169–2179.
  • Sozu, T., Sugimoto, T., Hamasaki, T. (2012). Sample size determination in clinical trials with multiple co-primary endpoints including mixed continuous and binary variables. Biometrical Journal 54(5):716–729.
  • Sugimoto, T., Sozu, T., Hamasaki, T. (2012). A convenient formula for sample size calculations in clinical trials with multiple co-primary continuous endpoints. Pharmaceutical Statistics 11(2):118–128.
  • Xu, H., Hsu, J. C. (2007). Applying the generalized partitioning principle to control the error rate. Biometrical Journal 49(1):52–67.

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.