The SEQDESIGN Procedure

References

  • Armitage, P., McPherson, C. K., and Rowe, B. C. (1969), “Repeated Significance Test on Accumulating Data,” Journal of the Royal Statistical Society, Series A, 132, 235–244.

  • 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. and Hinkley, D. V. (1974), Theoretical Statistics, London: Chapman & Hall.

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

  • Diggle, P. J., Heagerty, P., Liang, K.-Y., and Zeger, S. L. (2002), Analysis of Longitudinal Data, Second Edition, New York: Oxford University Press.

  • 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.

  • Efron, B. and Hinkley, D. V. (1978), “Assessing the Accuracy of the Maximum Likelihood Estimator: Observed versus Expected Fisher Information,” Biometrika, 65, 457–483.

  • 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., Kittelson, J. M., and Gillen, D. L. (2005), “On the Use of Stochastic Curtailment in Group Sequential Clinical Trials,” .
    URL http://www.bepress.com/uwbiostat/paper243

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

  • Haybittle, J. L. (1971), “Repeated Assessment of Results in Clinical Trials of Cancer Treatment,” British Journal of Radiology, 44, 793–797.

  • Hsieh, F. Y. and Lavori, P. W. (2000), “Sample-Size Calculations for the Cox Proportional Hazards Regression Model with Nonbinary Covariates,” Controlled Clinical Trials, 21, 552–560.

  • 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. (1990), “Statistical Approaches to Interim Monitoring of Medical Trials: A Review and Commentary,” Statistical Science, 5, 299–317.

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

  • Kalbfleisch, J. D. and Prentice, R. L. (1980), The Statistical Analysis of Failure Time Data, New York: John Wiley & Sons.

  • 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.

  • 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.

  • Lachin, J. M. and Foulkes, M. A. (1986), “Evaluation of Sample Size and Power for Analyses of Survival with Allowance for Nonuniform Patient Entry, Losses to Follow-Up, Noncompliance, and Stratification,” Biometrics, 42, 507–519.

  • Lan, K. K. G. and DeMets, D. (2009), “Further Comments on the Alpha-Spending Function,” Statistics in Biosciences, 1, 95–111.

  • 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.

  • Lindgren, B. W. (1976), Statistical Theory, Third Edition, New York: Macmillan.

  • 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.

  • O’Neill, R. T. (1994), Statistics in the Pharmaceutical Industry, chapter Interim Analysis, A Regulatory Perspective on Data Monitoring and Interim Analysis, 285–290, Marcel Dekker.

  • Pampallona, S. and Tsiatis, A. A. (1994), “Group Sequential Designs for One-Sided and Two-Sided Hypothesis Testing with Provision for Early Stopping in Favor of the Null Hypothesis,” Journal of Statistical Planning and Inference, 42, 19–35.

  • Peto, R., Pike, M. C., Armitage, P., Breslow, N. E., Cox, D. R., Howard, S. V., Mantel, N., McPherson, K., Peto, J., and Smith, P. G. (1976), “Design and Analysis of Randomized Clinical Trials Requiring Prolonged Observation of Each Patient: I. Introduction and Design,” British Journal of Cancer, 34, 585–612.

  • Pocock, S. J. (1977), “Group Sequential Methods in the Design and Analysis of Clinical Trials,” Biometrika, 64, 191–199.

  • Pocock, S. J. (1982), “Interim Analyses for Randomized Clinical Trials: The Group Sequential Approach,” Biometrics, 38, 153–162.

  • Pocock, S. J. and White, I. (1999), “Trials Stopped Early: Too Good to Be True?” Lancet, 353, 943–944.

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

  • 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.

  • Schoenfeld, D. A. (1983), “Sample-Size Formula for the Proportional-Hazards Regression Model,” Biometrics, 39, 499–503.

  • Senn, S. (1997), Statistical Issues in Drug Development, New York: John Wiley & Sons.

  • Snapinn, S. M. (2000), “Noninferiority Trials,” Current Controlled Trials in Cardiovascular Medicine, 1, 19–21.

  • Wang, S. K. and Tsiatis, A. A. (1987), “Approximately Optimal One Parameter Boundaries for Group Sequential Trials,” Biometrics, 43, 193–199.

  • 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.

  • Whitehead, J. (2001), Handbook of Statistics in Clinical Oncology, chapter Use of the Triangular Test in Sequential Clinical Trials, 211–228, New York: Marcel Dekker.

  • Whitehead, J. and Jones, D. R. (1979), “The Analysis of Sequential Clinical Trials,” Biometrika, 66, 443–452.

  • Whitehead, J. and Stratton, I. (1983), “Group Sequential Clinical Trials with Triangular Continuation Regions,” Biometrics, 39, 227–236.

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