References

De Castro, Mario, Vicente G Cancho, and Josemar Rodrigues. 2010. “A Hands-on Approach for Fitting Long-Term Survival Models Under the GAMLSS Framework.” Computer Methods and Programs in Biomedicine 97 (2): 168–77.
Downs, John R, Polly A Beere, Edwin Whitney, Michael Clearfield, Stephen Weis, Jeffrey Rochen, Evan A Stein, Deborah R Shapiro, Alexandra Langendorfer, and Antonio M Gotto Jr. 1997. “Design & Rationale of the Air Force/Texas Coronary Atherosclerosis Prevention Study (AFCAPS/TexCAPS).” The American Journal of Cardiology 80 (3): 287–93.
Downs, John R, Michael Clearfield, Stephen Weis, Edwin Whitney, Deborah R Shapiro, Polly A Beere, Alexandra Langendorfer, et al. 1998. “Primary Prevention of Acute Coronary Events with Lovastatin in Men and Women with Average Cholesterol Levels: Results of AFCAPS/TexCAPS.” Journal of the American Medical Association 279 (20): 1615–22.
Gandhi, Leena, Delvys Rodrı́guez-Abreu, Shirish Gadgeel, Emilio Esteban, Enriqueta Felip, Flávia De Angelis, Manuel Domine, et al. 2018. “Pembrolizumab Plus Chemotherapy in Metastatic Non–Small-Cell Lung Cancer.” New England Journal of Medicine 378 (22): 2078–92.
Gordon Lan, KK, and David L DeMets. 1983. “Discrete Sequential Boundaries for Clinical Trials.” Biometrika 70 (3): 659–63.
Harrington, David P, and Thomas R Fleming. 1982. “A Class of Rank Test Procedures for Censored Survival Data.” Biometrika 69 (3): 553–66.
Haybittle, JL. 1971. “Repeated Assessment of Results in Clinical Trials of Cancer Treatment.” The British Journal of Radiology 44 (526): 793–97.
Hellmann, Matthew David, Junshui Ma, Edward B Garon, Rina Hui, Leena Gandhi, Jean-Charles Soria, Keaven M Anderson, Gregory M Lubiniecki, Bilal Piperdi, and Roy S Herbst. 2017. “Estimating Long-Term Survival of PD-L1-Expressing, Previously Treated, Non-Small Cell Lung Cancer Patients Who Received Pembrolizumab in KEYNOTE-001 and-010.” American Society of Clinical Oncology.
Hwang, Irving K, Weichung J Shih, and John S De Cani. 1990. “Group Sequential Designs Using a Family of Type I Error Probability Spending Functions.” Statistics in Medicine 9 (12): 1439–45.
Jennison, Christopher, and Bruce W. Turnbull. 2000. Group Sequential Methods with Applications to Clinical Trials. Boca Raton, FL: Chapman; Hall/CRC.
Karrison, Theodore G. 2016. “Versatile Tests for Comparing Survival Curves Based on Weighted Log-Rank Statistics.” The Stata Journal 16 (3): 678–90.
Kim, Kyungmann, and Anastasios A. Tsiatis. 1990. “Study Duration for Clinical Trials with Survival Response and Early Stopping Rule.” Biometrics 46: 81–92.
Lachin, John M. 2005. “A Review of Methods for Futility Stopping Based on Conditional Power.” Statistics in Medicine 24 (18): 2747–64.
Lachin, John M., and Mary A. Foulkes. 1986a. “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: 507–19.
Lachin, John M, and Mary A Foulkes. 1986b. “Evaluation of Sample Size and Power for Analyses of Survival with Allowance for Nonuniform Patient Entry, Losses to Follow-up, Noncompliance, and Stratification.” Biometrics, 507–19.
Lan, K. K. G., and David L. DeMets. 1983. “Discrete Sequential Boundaries for Clinical Trials.” Biometrika 70: 659–63.
———. 1989. “Group Sequential Procedures: Calendar Versus Information Time.” Statistics in Medicine 8: 1191–98.
Lin, Ray S, Ji Lin, Satrajit Roychoudhury, Keaven M Anderson, Tianle Hu, Bo Huang, Larry F Leon, et al. 2020. “Alternative Analysis Methods for Time to Event Endpoints Under Nonproportional Hazards: A Comparative Analysis.” Statistics in Biopharmaceutical Research 12 (2): 187–98.
Magirr, Dominic, and Carl-Fredrik Burman. 2019b. “Modestly Weighted Logrank Tests.” Statistics in Medicine 38 (20): 3782–90.
———. 2019a. “Modestly Weighted Logrank Tests.” Statistics in Medicine 38 (20): 3782–90.
Maurer, Willi, and Frank Bretz. 2013. “Multiple Testing in Group Sequential Trials Using Graphical Approaches.” Statistics in Biopharmaceutical Research 5: 311–20.
Miettinen, Tatu A, Kalevi Pyörälä, Anders G Olsson, Thomas A Musliner, Thomas J Cook, Ole Faergeman, Kåre Berg, Terje Pedersen, John Kjekshus, and for the Scandinavian Simvastatin Study Group. 1997. “Cholesterol-Lowering Therapy in Women and Elderly Patients with Myocardial Infarction or Angina Pectoris: Findings from the Scandinavian Simvastatin Survival Study (4S).” Circulation 96 (12): 4211–18.
O’Brien, Peter C, and Thomas R Fleming. 1979. “A Multiple Testing Procedure for Clinical Trials.” Biometrics, 549–56.
Pocock, Stuart J. 1977. “Group Sequential Methods in the Design and Analysis of Clinical Trials.” Biometrika 64 (2): 191–99.
Roychoudhury, Satrajit, Keaven M Anderson, Jiabu Ye, and Pralay Mukhopadhyay. 2021. “Robust Design and Analysis of Clinical Trials with Non-Proportional Hazards: A Straw Man Guidance from a Cross-Pharma Working Group.” Statistics in Biopharmaceutical Research, 1–37.
Scharfstein, Daniel O, Anastasios A Tsiatis, and James M Robins. 1997. “Semiparametric Efficiency and Its Implication on the Design and Analysis of Group-Sequential Studies.” Journal of the American Statistical Association 92 (440): 1342–50.
Schoenfeld, David. 1981. “The Asymptotic Properties of Nonparametric Tests for Comparing Survival Distributions.” Biometrika 68 (1): 316–19.
Wang, Lili, Xiaodong Luo, and Cheng Zheng. 2019. “A Simulation-Free Group Sequential Design with Max-Combo Tests in the Presence of Non-Proportional Hazards.” arXiv Preprint arXiv:1911.05684.
Wang, Samuel K, and Anastasios A Tsiatis. 1987. “Approximately Optimal One-Parameter Boundaries for Group Sequential Trials.” Biometrics, 193–99.
White, William B, George L Bakris, Richard M Bergenstal, Christopher P Cannon, William C Cushman, Penny Fleck, Simon Heller, et al. 2011. “EXamination of cArdiovascular outcoMes with alogliptIN Versus Standard of carE in Patients with Type 2 Diabetes Mellitus and Acute Coronary Syndrome (EXAMINE): A Cardiovascular Safety Study of the Dipeptidyl Peptidase 4 Inhibitor Alogliptin in Patients with Type 2 Diabetes with Acute Coronary Syndrome.” American Heart Journal 162 (4): 620–26.
White, William B, Christopher P Cannon, Simon R Heller, Steven E Nissen, Richard M Bergenstal, George L Bakris, Alfonso T Perez, et al. 2013. “Alogliptin After Acute Coronary Syndrome in Patients with Type 2 Diabetes.” New England Journal of Medicine 369: 1327–35.
Yung, Godwin, and Yi Liu. 2019. “Sample Size and Power for the Weighted Log-Rank Test and Kaplan-Meier Based Tests with Allowance for Nonproportional Hazards.” Biometrics.
Zeng, Donglin, Guosheng Yin, and Joseph G Ibrahim. 2006. “Semiparametric Transformation Models for Survival Data with a Cure Fraction.” Journal of the American Statistical Association 101 (474): 670–84.
Zhang, Yilong, and Yongzhao Shao. 2018. “Concordance Measure and Discriminatory Accuracy in Transformation Cure Models.” Biostatistics 19 (1): 14–26.