Three-stage designs for monitoring clinical trials

References

• Armitage , P. , Mc Pherson , C. K. and Rowe , B. C. 1969 . Repeated significance tests on accumulating data . J. R. Statist. Soc. , 132 : 235 – 244 . Series A
   Google Scholar
• Case , L. D. , Morgan , T. M. and Davis , C. E. 1987 . Optimal restricted two-stage designs . Controlled Clinical Trials , 8 : 146 – 156 .
   PubMedGoogle Scholar
• Colton , T. 1963 . Optimal drug screening plans . Biometrika , 50 : 31 – 45 .
   Google Scholar
• Colton , T. and Mc Pherson , K. 1976 . Two-stage plans compared with fixed-sample-size and Wald SPRT plans . JASA , 71 : 80 – 86 .
   Web of Science ®Google Scholar
• De Mets , D. L. and Ware , J. H. 1980 . Group sequential methods for clinical trials with a one-sided hypothesis . Biometrika , 67 : 651 – 660 .
   Google Scholar
• De Mets , D. L. and Ware , J. H. 1982 . Asymmetric group sequential boundaries for monitoring clinical trials . Biometrika , 69 : 661 – 663 .
   Google Scholar
• De With , C. 1983 . Two-stage plans for the testing of binomial parameters . Controlled Clinical Trials , 4 : 215 – 226 .
   PubMedGoogle Scholar
• Donnely , T. G. 1973 . Algorithm 462-bivariate normal distribution [S15] . Communications of the Association of Computing Machines , 16 : 638 – 638 .
   Google Scholar
• Eales , J. D. and Jennison , C. 1992 . An improved method for deriving optimal one-sided group sequential tests . Biometrika , 79 : 13 – 24 .
   Web of Science ®Google Scholar
• Falissard , B. and Lellouch , J. 1991 . Some extensions to a new approach for interim analysis in clinical trials . Statistics in Medicine , 10 : 949 – 957 .
   PubMedGoogle Scholar
• Falissard , B. and Lellouch , J. 1992 . A new procedure for group sequential analysis in clinical trials . Biometrics , 48 : 373 – 388 .
   PubMed Web of Science ®Google Scholar
• Falissard , B. and Lellouch , J. 1993 . The succession procedure for interim analysis: extensions for early acceptance of H0 and for flexible times of analysis . Statistics in Medicine , 12 : 51 – 67 .
   PubMedGoogle Scholar
• Gould , A.L. and Pecore , V. J. 1982 . Group sequential methods for clinical trials allowing early acceptance and incorporating costs . Biometrika , 69 : 75 – 80 .
   Web of Science ®Google Scholar
• Hald , A. 1975 . Optimum double sampling tests of given strength . JASA , 70 : 451 – 456 .
   Google Scholar
• Halperin , M. , Lan , K.K.G. , Ware , J.H. , Johnson , N.J. and De Mets , D.L. 1982 . An aid to data monitoring in long-term clinical trials . Controlled Clinical Trials , 3 : 311 – 323 .
   PubMedGoogle Scholar
• Jennison , C. and Turnbull , B.W. 1990 . Statistical approaches to interim monitoring of medical trials: a review and commentary . Statistical Science , 5 : 299 – 317 .
   Google Scholar
• Kim , K. and De Mets , D.L. 1987 . Design and analysis of group sequential tests based on the type I error spending rate function . Biometrika , 74 : 149 – 154 .
   Web of Science ®Google Scholar
• Lan , K.K.G. , Simon , R. and Halperin , M. 1982 . Stochastically curtailed tests in long-term clinical trials . Comm in Statistics , 1 : 207 – 219 . Series C
   Google Scholar
• Lan , K.K.G. and De Mets , D.L. 1983 . Discrete sequential boundaries for clinical trials . Biometrika , 70 : 659 – 663 .
   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
• Owen , D. B. 1953 . A double sample procedure . Annals of Mathematical Statistics , 24 : 449 – 457 .
   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
• Pocock , S. J. 1992 . When to stop a clinical trial . BMJ , 305 : 235 – 240 .
   PubMed Web of Science ®Google Scholar
• Roseberry , T. D. and Gehan , E. A. 1964 . Operating characteristic curves and accept-reject rules for two and three stage screening procedures . Biometrics , 20 : 73 – 84 .
   Google Scholar
• Schervish , M. J. 1984 . Algorithm AS-195: multivariate normal probabilities with error bound . Applied Statistics , 33 : 81 – 94 .
   Web of Science ®Google Scholar
• Schervish , M. J. 1985 . Corrections: algorithm AS-195: multivariate normal probabilities with error bound . Applied Statistics , 34 : 103 – 104 .
   Google Scholar
• Simon , R. 1989 . Optimal two-stage designs for phase II clinical trials . Controlled Clinical Trials , 10 : 1 – 10 .
   PubMedGoogle Scholar
• Thall , P. F. , Simon , R. , Ellenberg , S. S. and Shrager , R. 1988 . Optimal two-stage designs for clinical trials with binary response . Statistics in Medicine , 7 : 571 – 579 .
   PubMedGoogle Scholar
• Tsiatis , A. A. 1981 . The asymptotic joint distribution of the efficient scores test for the proportional hazards model calculated over time . Biometrika , 68 : 311 – 315 .
   Web of Science ®Google Scholar
• Tsiatis , A. A. , Rosner , G. L. and Tritchler , D. L. 1985 . Group sequential tests with censored survival data adjusting for covariates . Biometrika , 72 : 365 – 373 .
   Web of Science ®Google Scholar
• Wald , A. 1947 . Sequential Analysis , New York : Wiley .
   Google Scholar
• Wald , A. and Wolfowitz , J. 1948 . Optimal character of the sequential probability ratio test . Annals of Mathematical Statistics , 19 : 326 – 339 .
   Google Scholar
• Ware , J.H. , Muller , J.E. and Braunwald , E. 1985 . The futility index: an approach to the cost-effective termination of randomized clinical trials . The American Journal of Medicine , 78 : 635 – 643 .
   PubMed Web of Science ®Google Scholar
• Whitehead , J. 1983 . The Design and Analysis of Sequential Clinical Trials , Chichester : Ellis Horwood Limited .
   Google Scholar