Randomized Two-Stage Phase II Clinical Trial Designs Based on Barnard's Exact Test

REFERENCES

• Barnard , G. A. ( 1945 ). A new test for 2 × 2 tables . Nature 156 : 177 .
   Web of Science ®Google Scholar
• Barnard , G. A. ( 1947 ). Significance tests for 2 × 2 tables . Biometrika 34 ( 1/2 ): 123 – 138 .
   PubMed Web of Science ®Google Scholar
• Berger , R. L. ( 1994 ). Power comparison of exact unconditional tests for comparing two binomial proportions. Technical report, Department of Statistics, North Carolina State University .
   Google Scholar
• Casella , G. , Berger , R. L. ( 2001 ). Statistica lInference. , 2nd ed. Belmont , CA : Duxbury Press .
   Google Scholar
• Eisenhauer , E. A. , Therasse , P. , Bogaerts , J. , Schwartz , L. H. , Sargent , D. , Ford , R. , Dancey , J. , Arbuck , S. , Gwyther , S. , Mooney , M. , Rubinstein , L. , Shankar , L. , Dodd , L. , Kaplan , R. , Lacombe , D. , Verweij , J. ( 2009 ). New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1) . European Journal of Cancer 45 ( 2 ): 228 – 247 .
   PubMed Web of Science ®Google Scholar
• Fisher , R. A. ( 1935 ). The logic of inductive inference . Journal of the Royal Statistical Society 98 ( 1 ): 39 – 82 .
   Google Scholar
• Fleming , T. R. ( 1982 ). One-sample multiple testing procedure for phase II clinical trials . Biometrics 38 ( 1 ): 143 – 151 .
   PubMed Web of Science ®Google Scholar
• Jung , S.-H. ( 2010 ). Randomized phase II clinical trials using fisher's exact test. Technical report, Duke University Department of Biostatistics and Bioinformatics .
   Google Scholar
• Kepner , J. , Chang , M. N. ( 2003 ). On the maximum total sample size of a group sequential test about binomial proportions . Statistics & Probability Letters 62 ( 1 ): 87 – 92 .
   Web of Science ®Google Scholar
• Kepner , J. L. ( 2010 ). On group sequential designs comparing two binomial proportions . Journal of Biopharmaceutical Statistics 20 ( 1 ): 145 – 159 .
   PubMed Web of Science ®Google Scholar
• Kocherginsky , M. , Cohen , E. E. W. , Karrison , T. ( 2009 ). Design of phase II cancer trials for evaluation of cytostatic/cytotoxic agents . Journal of Biopharmaceutical Statistics 19 ( 3 ): 524 – 529 .
   PubMed Web of Science ®Google Scholar
• Lee , J. J. , Feng , L. ( 2005 ). Randomized phase II designs in cancer clinical trials: Current status and future directions . Journal of Clinical Oncology 23 ( 19 ): 4450 – 4457 .
   PubMed Web of Science ®Google Scholar
• Lloyd , C. J. ( 2008 ). Exact p-values for discrete models obtained by estimation and maximization . Australian and New Zealand Journal of Statistics 50 ( 4 ): 329 – 345 .
   Web of Science ®Google Scholar
• Mehta , C. R. , Senchaudhuri , P. ( 2003 ). Conditional versus unconditional exact tests for comparing two binomials. Available at: http://www.cytel.com/papers/ twobinomials.pdf
   Google Scholar
• Shan , G. , Ma , C. ( 2012 ). Unconditional tests for comparing two ordered multinomials . Statistical Methods in Medical Research . doi: 10.1177/0962280212450957 .
   PubMedGoogle Scholar
• Shan , G. , Hutson , A. D. , Wilding , G. E. ( 2012a ). Two-stage k-sample designs for the ordered alternative problem . Pharmaceutical Statistics 11 ( 4 ): 287 – 294 .
   PubMed Web of Science ®Google Scholar
• Shan , G. , Ma , C. , Hutson , A. D. , Wilding , G. E. ( 2012b ). An efficient and exact approach for detecting trends with binary endpoints . Statistics in Medicine 31 ( 2 ): 155 – 164 .
   PubMed Web of Science ®Google Scholar
• Shan , G. , Ma , C. , Hutson , A. D. , Wilding , G. E. ( 2013 ). Some tests for detecting trends based on the modified Baumgartner-Weiß-Schindler statistics . Computational Statistics and Data Analysis 57 ( 1 ): 246 – 261 .
   Web of Science ®Google Scholar
• Simon , R. ( 1989 ). Optimal two-stage designs for phase II clinical trials . Controlled Clinical Trials 10 ( 1 ): 1 – 10 .
   PubMedGoogle Scholar
• Simon , R. , Wittes , R. E. , Ellenberg , S. S. ( 1985 ). Randomized phase II clinical trials . Cancer Treatment Reports 69 ( 12 ): 1375 – 1381 .
   PubMedGoogle Scholar
• Sylvester , R. ( 1980 ). WHO handbook for reporting results of cancer treatment. WHO offset publication #48, World Health Organization . Controlled Clinical Trials 1 ( 3 ): 276 – 277 .
   Google Scholar
• Taylor , J. M. G. , Braun , T. M. , Li , Z. (2006). Comparing an experimental agent to a standard agent: Relative merits of a one-arm or randomized two-arm phase II design. Clinical Trials 3(4):335–348.
   PubMed Web of Science ®Google Scholar
• Therasse , P. , Arbuck , S. G. , Eisenhauer , E. A. , Wanders , J. , Kaplan , R. S. , Rubinstein , L. , Verweij , J. , Van Glabbeke , M. , Van Oosterom , A. T. , Christian , M. C. , Gwyther , S. G. ( 2000 ). New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada . Journal of the National Cancer Institute 92 ( 3 ): 205 – 216 .
   PubMed Web of Science ®Google Scholar
• Wilding , G. E. , Shan , G. , Hutson , A. D. ( 2012 ). Exact two-stage designs for phase II activity trials with rank-based endpoints . Contemporary Clinical Trials 33 ( 2 ): 332 – 341 .
   PubMed Web of Science ®Google Scholar