Stopping rules for long-term clinical trials based on two consecutive rejections of the null hypothesis

References

• Armitage, P., McPherson, C.K., Rowe, B.C. (1969). Repeated significance tests on accumulating data. J. R. Stat. Soc. A 132:235–244.
   Web of Science ®Google Scholar
• Armitage, P., McPherson, C.K. (1971). Repeated significance tests on accumulating data when the null hypothesis is not true. J.R. Stat. Soc. 134:15–25.
   Google Scholar
• Pocock, S.J. (1977). Group sequential methods in the design and analysis of clinical trials. Biometrika. 64(2):191–199.
   Web of Science ®Google Scholar
• O'Brien, P., Fleming, T. (1979). A multiple testing procedure. Biometrics. 35:549–556.
   PubMed Web of Science ®Google Scholar
• Tsiatis, A.A. (1982). Repeated significance testing for a general class of statistics used in censored survival data. JASA. 77:380.
   Web of Science ®Google Scholar
• Slud, E., Wei, J.J. (1982). Two sample repeated significance tests based on the modified Wilcoxon Statistic. JASA. 77:380.
   Web of Science ®Google Scholar
• DeMets, D.L., Ware, J.H. (1982). Asymmetric group sequential boundaries for monitoring clinical trials. Biometrika. 6(3):661–663.
   Google Scholar
• Lan, G., Demets, D.L. (1983). Discrete sequential boundaries for clinical trials. Biometrika. 70(3):659–663.
   Web of Science ®Google Scholar
• DeMets, D.L., Gail, M.H. (1985). Use of logrank tests and group sequential methods at fixed calendar times. Biometrics. 41:1039–1044.
   PubMed Web of Science ®Google Scholar
• Fleming, T.R., Harrington, D.P., O'Brien, P.C. (1984). Designs for group sequential tests. Controlled Clin. Trials. 5:384–361.
   Google Scholar
• Green, S.J., Fleming, T.R., Emerson, S. (1987). Effects on overviews of early stopping rules for clinical trials. Stat. Med. 6(3):361–369.
   PubMed Web of Science ®Google Scholar
• Storer, B.E. (1990). A sequential phase II/III trial for binary outcomes. Stat Med. 9(3):229–235.
   PubMed Web of Science ®Google Scholar
• Davis, B.R., Hardy, R.J. (1994). Data monitoring in clinical trials: the case for stochastic curtailment. J. Clin. Epidemiol. 47(9):1033–1042.
   PubMed Web of Science ®Google Scholar
• Karrison, T.G., Huo, D., Chappell, R. (2003). A group sequential, response-adaptive design for randomized clinical trials. Control Clin. Trials. 24(5):506–522.
   PubMedGoogle Scholar
• Jennison, C., Turnbull, B.W. (2000). Group Sequential Methods with Applications to Clinical Trials. Boca Raton: Chapman & Hall/CRC.
   Google Scholar
• Xiong, X., Tan, M., Boyett, J. (2003). Sequential conditional probability ratio tests for normalized test statistic on information time. Biometrics. 59(3):624–631.
   PubMed Web of Science ®Google Scholar
• Tan, M., Xiong, X., Kutner, M.H. (1998). Clinical trial designs based on sequential conditional probability ratio tests and reverse stochastic curtailing. Biometrics. 54:682–695.
   PubMed Web of Science ®Google Scholar
• Xiong, X. (1995). A class of sequential conditional probability ratio tests. J. Am. Stat. Assoc. 90(432):1463–1473.
   Web of Science ®Google Scholar
• Brannath, W.P., Maurer, B.W., Posch, M. (2003). Sequential tests for non inferiority and superiority. Biometrics. 59(1):106. doi:10.1111/1541-0420.00013
   PubMed Web of Science ®Google Scholar
• Burington, B.E., Emerson, S.S. (2003). Flexible implementations of group sequential stopping rules using constrained boundaries. Biometrics. 59(4):770. doi:10.1111/j.0006-341X.2003.00090.x
   PubMed Web of Science ®Google Scholar
• Hulot, J.-S., Cucherat, M., Charlesworth, A., Veldhuisen, D.J., Corvol, J.-C., Mallet, A., Boissel, J.-P., Hampton, J., Lechat, P. (2003). Planning and monitoring of placebo-controlled survival trials : comparison of the triangular test with usual interim analyses methods. Br. J. Clin. Pharmacol. 55(3):299. doi:10.1046/j.1365-2125.2003.01768.x
   PubMed Web of Science ®Google Scholar
• Freedman, L.S., Spiegelhalter, D.J., Parmer, M.KB. (1989). Comparison of Bayesian with group sequential methods for monitoring clinical trials. Controlled Clin Trials. 10:357–367.
   PubMedGoogle Scholar
• Mubasher (Hussein), M.E. (1990). Procedure for stopping long-term clinical trials, Ph.D. Thesis, University of Pittsburgh, Pittsburgh, PA.
   Google Scholar
• Mubasher (Hussein), M.E., Rockette, H.E. (1991). Procedure for stopping long-term clinical trials. Proceedings of the Biometric Society Meeting, ENAR, Houston TX.
   Google Scholar
• Fallisard, B., Lellouch, J. (1992). A new procedure for group sequential analysis in clinical trials. Biometrics. 48(2):361–372.
   PubMed Web of Science ®Google Scholar
• IMSL, IMSL Library. (1985). FORTRAN Subroutines for Mathematics and Statistics. volume 2, IMSL, Inc.
   Google Scholar
• Cox, D.R., Oakes, D. (1984). Analysis of Survival Data. London, UK: Chapman & Hall.
   Google Scholar
• Mantel, N. (1966). Evaluation of survival data and two new rank order statistics arising in its consideration. Cancer Chemotherapy Resp. 50:163.
   PubMedGoogle Scholar
• Cox, D.R. (1972). Regression model and life-tables. J. Royal Stat. Soc. B34:187–220.
   Google Scholar