Group Sequential Survival Trial Design and Monitoring Using the Log-Rank Test

References

• Ahnn, S., and Anderson, S. J. (1995), “Sample Size Determination for Comparing More than Two Survival Distributions,” Statistics in Medicine, 14, 2273–2282.
   PubMed Web of Science ®Google Scholar
• ——— (1998), “Sample Size Determination in Complex Clinical Trials Comparing More than Two Groups for Survival Endpoints,” Statistics in Medicine, 17, 2525–2534.
   Google Scholar
• Barthel, F. M. S., Babiker, A. G., Royston, P., and Parmar, M. K. B. (2006), “Evaluation of Sample Size and Power for Multi-Arm Survival Trials Allowing for Non-Uniform Accrual, Non-Proportional Hazards, Loss to Follow-up and Cross-Over,” Statistics in Medicine, 25, 2521–2542.
   PubMed Web of Science ®Google Scholar
• Collett, D. (2003), Modeling Survival Data in Medical Research (2nd ed.), London: Chapman and Hall.
   Google Scholar
• Cytel Software Corporation (2007), EAST Version 5.4, Cambridge, MA: Cytel.
   Google Scholar
• Freedman, L. S. (1982), “Tables of the Number of Patients Required in Clinical Trials Using the Logrank Test,” Statistics in Medicine, 1, 121–129.
   PubMedGoogle Scholar
• Halabi, S., and Singh, B. (2004), “Sample Size Determination for Comparing Several Survival Curves With Unequal Allocations,” Statistics in Medicine, 23, 1793–1815.
   PubMed Web of Science ®Google Scholar
• Haybittle, J. L. (1971), “Repeated Assessment of Results in Clinical Trials of Cancer Treatment,” British Journal of Radiology, 44, 793–797.
   PubMed Web of Science ®Google Scholar
• Hsieh, F. Y. (1992), “Comparing Sample Size Formulae for Trials With Unbalanced Allocation Using the Logrank Test,” Statistics in Medicine, 11, 1091–1098.
   PubMed Web of Science ®Google Scholar
• Jennison, C., and Turnbull, B. W. (1997), “Group-Sequential Analysis Incorporating Covariate Information,” Journal of the American Statistical Association, 92, 1330–1341.
   Web of Science ®Google Scholar
• ——— (2000), Group Sequential Methods With Applications to Clinical Trials, New York: Chapman and Hall.
   Google Scholar
• Kooperberg, C., and Stone, C. J. (1992), “Logspline Density Estimation for Censored Data,” Journal of Computational and Graphical Statistics, 1, 301–328.
   Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• Lakatos, E. (1988), “Sample Sizes Based on the Log-Rank Statistic in Complex Cilinical Trials,” Biometrics, 44, 229–241.
   PubMed Web of Science ®Google Scholar
• ——— (2002), “Designing Complex Group Sequential Survival Trials,” Statistics in Medicine, 21, 1969–1989.
   PubMed Web of Science ®Google Scholar
• Lan, K. K. G., and DeMets, D. L. (1983), “Discrete Sequential Boundaries for Clinical Trials,” Biometrika, 70, 659–663.
   Web of Science ®Google Scholar
• Lan, K. K. G., and Lachin, J. M. (1990), “Implementation of Group Sequential Logrank Tests in a Maximum Duration Trial,” Biometrics, 46, 759–770.
   PubMed Web of Science ®Google Scholar
• Lan, K. K. G., and Zucker, D. M. (1993), “Sequential Monitoring of Clinical Trials: The Role of Information and Brownian Motion,” Statistics in Medicine, 12, 753–765.
   PubMed Web of Science ®Google Scholar
• O’Brien, P. C., and Fleming, T. R. (1979), “A Multiple Testing Procedure for Clinical Trials,” Biometrics, 35, 549–556.
   PubMed Web of Science ®Google Scholar
• Pocock, S. J. (1977), “Group Sequential Methods in the Design and Analysis of Clinical Trials,” Biometrika, 64, 191–199.
   Web of Science ®Google Scholar
• Rubinstein, L. V., Gail, M. H., and Santner, T. J. (1981), “Planning the Duration of a Comparative Clinical Trial With Loss to Follow-Up and a Period of Continued Observation,” Journal of Chronic Diseases, 34, 469–479.
   PubMedGoogle Scholar
• Schoenfeld, D. (1981), “The Asymptotic Properties of Nonparametric Tests for Comparing Survival Distributions,” Biometrika, 68, 316–319.
   Web of Science ®Google Scholar
• Schoenfeld, D. A. (1983), “Sample-Size Formula for the Proportional-Hazards Regression Model,” Biometrics, 39, 499–503.
   PubMed Web of Science ®Google Scholar
• Sellke, T., and Siegmund, D. (1983), “Sequential Analysis of the Proportional Hazards Model,” Biometrika, 79, 315–326.
   Google Scholar
• Slud, E. V. (1984), “Sequential Linear Rank Tests for Two-Sample Censored Survival Data,” Annals of Statistics, 12, 551–571.
   Web of Science ®Google Scholar
• Tsiatis, A. A. (1982), “Repeated Significance Testing for a General Class of Statistics Used in Censored Survival Analysis,” Journal of the American Statistical Association, 77, 855–861.
   Web of Science ®Google Scholar
• Whitehead, J., and Stratton, I. (1983), “Group Sequential Clinical Trial With Triangular Continuation Regions,” Biometrics, 39, 227–236.
   PubMed Web of Science ®Google Scholar
• Wu, J., and Xiong, X. (2016), “Group Sequential Design for Randomized Phase III Trials Under the Weibull Model,” Journal of Biopharmaceutical Statistics, 8, 1–9.
   Web of Science ®Google Scholar
• Xiong, X. (1995), “A Class of Sequential Conditional Probability Ratio Tests,” Journal of American Statistical Association, 15, 1463–1473.
   Google Scholar
• ——— (2007), A Computer Program for SCPRT on Information Time, Version 1.0. Available at http://www.stjuderesearch.org/site/depts/biostats/scprt
   Google Scholar
• ——— (2014), “A Precise Approach for Sequential Test Design on Comparing Survival Distributions by Log-Rank Test,” unpublished manuscript.
   Google Scholar
• Xiong, X., Tan, M., and Boyett, J. (2003), “Sequential Conditional Probability Ratio Tests for Normalized Test Statistic on Information Time,” Biometrics, 59, 624–631.
   PubMed Web of Science ®Google Scholar