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Original Articles

An Adaptive Approach to Implementing Bivariate Group Sequential Clinical Trial Designs

Pages 605-619 | Published online: 02 Feb 2007

References

  • Armitage , P. , McPherson , C. K. and Rowe , B. C. 1969 . Repeated significance tests on accumulating data . J. Roy. Statist. Soc. , A 132 : 235 – 244 .
  • Bauer , P. and Kohne , K. 1994 . Evaluation of experiments with adaptive interim analyses . Biometrics , 50 : 1029 – 1041 .
  • Cardozo , L. , Chapple , C. R. , Toozs-Hobson , P. , Grosse-Freese , M. , Bulitta , M. , Lehmacher , W. , Strosser , W. , Ballering-Bruhl , B. and Schafer , M. 2000 . Efficacy of trospium chloride in patients with detrusor instability: a placebo-controlled, randomised, double-blind, multicentre clinical trial . BJU International , 85 : 659 – 664 .
  • Cook , R. J. 1994 . Interim monitoring of bivariate responses using repeated confidence intervals . Controlled Clin. Trials , 15 : 187 – 200 .
  • Cook , R. J. and Farewell , V. T. 1994 . Guidelines for monitoring efficacy and toxicity responses in clinical trials . Biometrics , 50 : 1146 – 1152 .
  • Fairbanks , K. and Madsen , R. 1982 . P values for tests using a repeated significance test design . Biometrika , 69 : 69 – 74 .
  • Jennison , C. and Turnbull , B. W. 1993 . Group sequential tests for bivariate response: interim analyses of clinical trials with both efficacy and safety endpoints . Biometrics , 49 : 741 – 752 .
  • Jennison , C. and Turnbull , B. W. 1997 . Group-sequential analysis incorporating covariate information . J. Amer. Statist. Assoc. , 92 : 1330 – 1341 .
  • Kim , K. and DeMets , D. L. 1987 . Design and analysis of group sequential tests based on the type I error spending rate function . Biometrika , 74 : 149 – 154 .
  • Lan , K. K. G. and DeMets , D. L. 1983 . Discrete sequential boundaries for clinical trials . Biometrika , 70 : 659 – 663 .
  • Lin , D. Y. 1991 . Nonparametric sequential testing in clinical trials with incomplete multivariate observations . Biometrika , 78 : 123 – 131 .
  • O'Brien , P. C. and Fleming , T. R. 1979 . A multiple testing procedure for clinical trials . Biometrics , 35 : 549 – 556 .
  • Pampallona, S., Tsiatis, A. A., Kim, K. (1995)., Spending Functions for the Type I and Type II Error Probabilities of Group Sequential Tests. Technical Report, Department of Biostatistics, Harvard School of Public Health
  • Pocock , S. J. 1977 . Group sequential methods in the design and analysis of clinical trials . Biometrika , 64 : 191 – 199 .
  • Scharfstein , D. O. , Tsiatis , A. A. and Robins , J. M. 1997 . Semiparametric efficiency and its implication on the design and analysis of group-sequential studies . J. Amer. Statist. Assoc. , 92 : 1342 – 1350 .
  • Thall , P. F. and Cheng , S.-C. 1999 . Treatment comparisons based on two-dimensional safety and efficacy alternatives in oncology trials . Biometrics , 55 : 746 – 753 .
  • Todd , S. , Whitehead , J. and Facey , K. M. 1996 . Point and interval estimation following a sequential trial . Biometrika , 83 : 453 – 461 .
  • Todd , S. 1999 . Sequential designs for monitoring two endpoints in a clinical trial . Drug Information J. , 33 : 417 – 426 .
  • Tsiatis , A. A. , Rosner , G. L. and Mehta , C. R. 1984 . Exact confidence intervals following a group sequential test . Biometrics , 40 : 797 – 803 .
  • Vincent , E. , Todd , S. and Whitehead , J. 2002 . A sequential procedure for comparing two experimental treatments with a control . J. Biopharm. Statist. , 12 : 249 – 265 .
  • Whitehead , J. 1997 . The Design and Analysis of Sequential Clinical Trials , Revised 2nd Chichester : Ellis Horwood .

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