The SEQDESIGN Procedure |

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.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,"

*UW Biostatistics Working Paper Series*,*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,"

*Brit. J. 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.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, New York: Chapman & Hall/CRC.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), "Interim Analysis, A Regulatory Perspective on Data Monitoring and Interim Analysis,"

*Statistics in the Pharmaceutical Industry,*Revised and Expanded Second Edition, ed. C. R. Buncher and J-Y Tsay, New York: Marcel Dekker, 285–290.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,"

*J. Statist. Planning and Inference*, 42, 19–35.Peto, R., Pike, M. C., et al. (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 & Type II Error Spending for Two-Sided Group Sequential Designs,"

*Contemporary Clinical Trials*, doi:10.1016/j.cct.2007.09.002.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, 193–200.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: John Wiley & Sons.Whitehead, J. (2001), "Use of the Triangular Test in Sequential Clinical Trials,"

*Handbook of Statistics in Clinical Oncology,*ed. J. Crowley, New York: Marcel Dekker, 211–228.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.

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