References
Anderson, Keaven M, and Jason B Clark. 2010. “Fitting Spending
Functions.” Statistics in Medicine 29 (3): 321–27.
Anderson, Keaven M, Zifang Guo, Jing Zhao, and Linda Z Sun. 2022.
“A Unified Framework for Weighted Parametric Group Sequential
Design.” Biometrical Journal 64 (7): 1219–39.
Armitage, Peter, CK McPherson, and BC Rowe. 1969. “Repeated
Significance Tests on Accumulating Data.” Journal of the
Royal Statistical Society: Series A (General) 132 (2): 235–44.
Chan, Ivan SF, and Norman R Bohidar. 1998. “Exact Power and Sample
Size for Vaccine Efficacy Studies.” Communications in
Statistics - Theory and Methods 27 (6): 1305–22.
Chen, YH Joshua, David L DeMets, and K K Gordon Lan. 2004.
“Increasing the Sample Size When the Unblinded Interim Result Is
Promising.” Statistics in Medicine 23 (7): 1023–38.
DeMets, David L, Curt D Furberg, and Lawrence M Friedman, eds. 2006.
Data Monitoring in Clinical Trials: A Case Studies Approach.
New York: Springer.
Farrington, Conor P, and Godfrey Manning. 1990. “Test Statistics
and Sample Size Formulae for Comparative Binomial Trials with Null
Hypothesis of Non-Zero Risk Difference or Non-Unity Relative
Risk.” Statistics in Medicine 9 (12): 1447–54.
Fleiss, Joseph L, Alex Tytun, and Hans K Ury. 1980. “A Simple
Approximation for Calculating Sample Sizes for Comparing Independent
Proportions.” Biometrics 36 (2): 343–46.
Gordon, Ian, and Ray Watson. 1996. “The Myth of
Continuity-Corrected Sample Size Formulae.” Biometrics
52 (1): 71–76.
Jennison, Christopher, and Bruce W Turnbull. 2000. Group Sequential
Methods with Applications to Clinical Trials. Boca Raton, FL:
Chapman & Hall/CRC.
Kim, Kyungmann, and Anastasios A Tsiatis. 1990. “Study Duration
for Clinical Trials with Survival Response and Early Stopping
Rule.” Biometrics 46 (1): 81–92.
Lachin, John M, and Mary A Foulkes. 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 (3): 507–19.
Lan, K K Gordon, and David L DeMets. 1983. “Discrete Sequential
Boundaries for Clinical Trials.” Biometrika 70 (3):
659–63.
———. 1989. “Group Sequential Procedures: Calendar Versus
Information Time.” Statistics in Medicine 8 (10):
1191–98.
Lehmacher, Walter, and Gernot Wassmer. 1999. “Adaptive Sample Size
Calculations in Group Sequential Trials.” Biometrics 55
(4): 1286–90.
Maurer, Willi, and Frank Bretz. 2013. “Multiple Testing in Group
Sequential Trials Using Graphical Approaches.” Statistics in
Biopharmaceutical Research 5 (4): 311–20.
Miettinen, Olli, and Markku Nurminen. 1985. “Comparative Analysis
of Two Rates.” Statistics in Medicine 4 (2): 213–26.
Müller, Hans-Helge, and Helmut Schäfer. 2004. “A General
Statistical Principle for Changing a Design Any Time During the Course
of a Trial.” Statistics in Medicine 23 (16): 2497–2508.
O’Brien, Peter C, and Thomas R Fleming. 1979. “A Multiple Testing
Procedure for Clinical Trials.” Biometrics 35 (3):
549–56.
Pocock, Stuart J. 1977. “Group Sequential Methods in the Design
and Analysis of Clinical Trials.” Biometrika 64 (2):
191–99.
Polack, Fernando P., Stephen J. Thomas, Nicholas Kitchin, Judith
Absalon, Alejandra Gurtman, Stephen Lockhart, John L. Perez, et al.
2020. “Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine.”
New England Journal of Medicine 383 (27): 2603–15.
Proschan, Michael A, K K Gordon Lan, and Janet Turk Wittes. 2006.
Statistical Monitoring of Clinical Trials: A Unified Approach.
New York: Springer.
Rodrigues, Josemar, Vicente G Cancho, Mário de Castro, and Francisco
Louzada-Neto. 2009. “On the Unification of Long-Term Survival
Models.” Statistics & Probability Letters 79 (6):
753–59.
Snedecor, George W, and William G Cochran. 1989. Statistical
Methods. Eighth. Ames, IA: Iowa State University Press.
The CAPTURE Investigators. 1997. “Randomised Placebo-Controlled
Trial of Abciximab Before and During Coronary Intervention in Refractory
Unstable Angina: The CAPTURE Study.” The
Lancet 349 (9063): 1429–35.
Whitehead, John. 1992. “Overrunning and Underrunning in Sequential
Clinical Trials.” Controlled Clinical Trials 13 (2):
106–21.
Zhou, Jing, Adeniyi Adewale, Yue Shentu, Jiajun Liu, and Keaven
Anderson. 2014. “Information-Based Sample Size Re-Estimation in
Group Sequential Design for Longitudinal Trials.” Statistics
in Medicine 33 (22): 3801–14.