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Articles

Estimating the subgroup and testing for treatment effect in a post-hoc analysis of a clinical trial with a biomarker

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References

  • Alosh, M., and M. F. Huque. 2009. A flexible strategy for testing subgroups and overall population. Statistics in Medicine 28:3–23. doi:10.1002/sim.3461.
  • Arnold, B. C., R. J. Beaver, R. A. Groeneveld, and W. Q. Meeker. 1993. The nontruncated marginal of a truncated bivariate normal distribution. Psychometrika 58:471. doi:10.1007/BF02294652.
  • Diao, G., J. Dong, D. Zeng, C. Ke, A. Rong, and J. G. Ibrahim. 2018. Biomarker threshold adaptive designs for survival endpoints. Journal of Biopharmaceutical Statistics 28 (6):1038–1054.
  • Foster, J., J. Taylor, and S. Ruberg. 2011. Subgroup identification from randomized clinical trial data. Statistics in Medicine 30 (24):2867–2880. doi:10.1002/sim.v30.24.
  • Freidlin, B., and R. Simon. 2005. Adaptive signature design: An adaptive clinical trial design for generating and prospectively testing a gene expression signature for sensitive patients. Clinical Cancer Research 11:7872–7878. doi:10.1158/1078-0432.CCR-05-0605.
  • Freidlin, B., W. Jiang, and R. Simon. 2010. The cross-validated adaptive signature design. Clinical Cancer Research 16 (2):691–698. doi:10.1158/1078-0432.CCR-10-0613.
  • Jenkins, M., A. Stone, and C. Jennison. 2011. An adaptive seamless phase II/III design for oncology trials with subpopulation selection using correlated survival endpoints. Pharmaceutical Statistics 10:347–356. doi:10.1002/pst.472.
  • Jiang, W., B. Freidlin, and R. Simon. 2007. Biomarker-adaptive threshold design: A procedure for evaluating treatment with possible biomarker-defined subset effect. Journal of the National Cancer Institute 99:1036–1043. doi:10.1093/jnci/djm022.
  • Kehl, V., and K. Ulm. 2006. Responder identification in clinical trials with censored data. Computational Statistics & Data Analysis 50:1338–1355. doi:10.1016/j.csda.2004.11.015.
  • Lai, T., P. Lavori, and O. Liao. 2014. Adaptive choice of patient subgroup for comparing two treatments. Contemporary Clinical Trials 39 (2):191–200. doi:10.1016/j.cct.2014.09.001.
  • Lipkovich, I., A. Dmitrienko, J. Denne, and G. Enas. 2011. Subgroup identification based on differential effect search–A recursive partitioning method for establishing response to treatment in patient subpopulations. Statistics in Medicine 30 (21):2601–2621.
  • Renfro, L. A., C. M. Coughlin, A. M. Grothey, and D. J. Sargent. 2014. Adaptive randomized phase II design for biomarker threshold selection and independent evaluation. Chinese Clinical Oncology 3 (1):3489. doi:10.3978/j.issn.2304-3865.2014.06.02.
  • Simon, N., and R. Simon. 2013. Adaptive enrichment designs for clinical trials. Biostatistics 14 (4):613–625. doi:10.1093/biostatistics/kxt010.
  • Song, Y., and G. Y. Chi. 2007. A method for testing a prespecified subgroup in clinical trials. Statistics in Medicine 26:3535–3549. doi:10.1002/sim.2825.
  • Su, X. G., C. L. Tsai, H. S. Wang, D. M. Nickerson, and B. G. Li. 2009. Subgroup analysis via recursive partitioning. Journal of Machine Learning Research 10:141–158.
  • Wolpin, B. M., E. M. O’Reilly, Y. J. Ko, L. S. Blaszkowsky, M. Rarick, C. M. Rocha-Lima, P. Ritch, E. Chan, J. Spratlin, T. Macarulla, et al. 2013. Global, multicenter, randomized, phase II trial of gemcitabine and gemcitabine plus AGS-1C4D4 in patients with previously untreated, metastatic pancreatic cancer. Annals of Oncology 24:1792–1801. doi:10.1093/annonc/mdt066.
  • Zhang, Z., M. Li, M. Lin, G. Soon, T. Greene, and C. Shen. 2017. Subgroup selection in adaptive signature designs of confirmatory clinical trials. Journal of the Royal Statistical Society C 66:345–361. doi:10.1111/rssc.12175.

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