The SEQTEST Procedure

References

  • Chang, M. N. (1989), “Confidence Intervals for a Normal Mean Following a Group Sequential Test,” Biometrics, 45, 247–254.

  • Chang, M. N., Gould, A. L., and Snapinn, S. M. (1995), “p-Values for Group Sequential Testing,” Biometrika, 82, 650–654.

  • Chow, S. C. and Liu, J. P. (1998), Design and Analysis of Clinical Trials, Concept and Methodologies, New York: John Wiley & Sons.

  • Chow, S.-C., Shao, J., and Wang, H. (2003), Sample Size Calculations in Clinical Research, Boca Raton, FL: CRC Press.

  • Cox, D. R. (1972), “Regression Models and Life Tables,” Journal of the Royal Statistical Society, Series B, 20, 187–220, with discussion.

  • DeMets, D. L., Furberg, C. D., and Friedman, L. M. (2006), Data Monitoring in Clinical Trials, New York: Springer.

  • Dmitrienko, A., Molenberghs, G., Chuang-Stein, C., and Offen, W. (2005), Analysis of Clinical Trials Using SAS: A Practical Guide, Cary, NC: SAS Institute Inc.

  • Ellenberg, S. S., Fleming, T. R., and DeMets, D. L. (2003), Data Monitoring Committees in Clinical Trials, New York: John Wiley & Sons.

  • Emerson, S. S. (1996), “Statistical Packages for Group Sequential Methods,” The American Statistician, 50, 183–192.

  • Emerson, S. S. and Fleming, T. R. (1989), “Symmetric Group Sequential Designs,” Biometrics, 45, 905–923.

  • Emerson, S. S. and Fleming, T. R. (1990), “Parameter Estimation Following Group Sequential Hypothesis Testing,” Biometrika, 77, 875–892.

  • Fairbanks, K. and Madsen, R. (1982), “p-Values for Tests Using a Repeated Significance Test Design,” Biometrika, 69, 69–74.

  • Food and Drug Administration (1998), “E9: Statistical Principles for Clinical Trials,” Federal Register, 63 (179), 49583–49598.

  • Herson, J. (1979), “Predictive Probability Early Termination for Phase II Clinical Trials,” Biometrics, 35, 775–783.

  • Hwang, I. K., Shih, W. J., and DeCani, J. S. (1990), “Group Sequential Designs Using a Family of Type I Error Probability Spending Functions,” Statistics in Medicine, 9, 1439–1445.

  • Jennison, C. and Turnbull, B. W. (2000), Group Sequential Methods with Applications to Clinical Trials, New York: Chapman & Hall.

  • Kim, K. and Tsiatis, A. A. (1990), “Study Duration for Clinical Trials with Survival Response and Early Stopping Rule,” Biometrics, 46, 81–92.

  • Kittelson, J. M. and Emerson, S. S. (1999), “A Unifying Family of Group Sequential Test Designs,” Biometrics, 55, 874–882.

  • Lan, K. K. G. and DeMets, D. L. (1983), “Discrete Sequential Boundaries for Clinical Trials,” Biometrika, 70, 659–663.

  • Lan, K. K. G., Lachin, J. M., and Bautista, O. (2003), “Over-Ruling a Group Sequential Boundary: A Stopping Rule versus a Guideline,” Statistics in Medicine, 22, 3347–3355.

  • Lan, K. K. G., Simon, R., and Halperin, M. (1982), “Stochastically Curtailed Tests in Long-Term Clinical Trials,” Sequential Analysis, 1, 207–219.

  • McCullagh, P. and Nelder, J. A. (1989), Generalized Linear Models, Second Edition, London: Chapman & Hall.

  • Mehta, C. R. and Tsiatis, A. A. (2001), “Flexible Sample Size Considerations under Information Based Interim Monitoring,” Drug Information Journal, 35, 1095–1112.

  • O’Brien, P. C. and Fleming, T. R. (1979), “A Multiple Testing Procedure for Clinical Trials,” Biometrics, 35, 549–556.

  • Proschan, M. A., Lan, K. K. G., and Wittes, J. T. (2006), Statistical Monitoring of Clinical Trials, New York: Springer.

  • Rosner, G. L. and Tsiatis, A. A. (1988), “Exact Confidence Intervals Following a Group Sequential Trial: A Comparison of Methods,” Biometrika, 75, 723–729.

  • Rudser, K. D. and Emerson, S. S. (2007), “Implementing Type I and Type II Error Spending for Two-Sided Group Sequential Designs,” Contemporary Clinical Trials, 29, 351–358.

  • Scharfstein, D. O. and Tsiatis, A. A. (1998), “The Use of Simulation and Bootstrap in Information-Based Group Sequential Studies,” Statistics in Medicine, 17, 75–87.

  • Tsiatis, A. A. and Mehta, C. R. (2003), “On the Inefficiency of the Adaptive Design for Monitoring Clinical Trials,” Biometrika, 90, 367–378.

  • Tsiatis, A. A., Rosner, G. L., and Mehta, C. R. (1984), “Exact Confidence Intervals Following a Group Sequential Test,” Biometrics, 40, 797–803.

  • Ware, J. H., Muller, J. E., and Braunwald, E. (1985), “The Futility Index: An Approach to the Cost-Effective Termination of Randomized Clinical Trials,” American Journal of Medicine, 78, 635–643.

  • Whitehead, J. (1997), The Design and Analysis of Sequential Clinical Trials, Revised Second Edition, Chichester, UK: John Wiley & Sons.

  • Zhu, L., Ni, L., and Yao, B. (2011), “Group Sequential Methods and Software Applications,” The American Statistician, 65, 127–135.