Sample size re-estimation without unblinding for normally distributed outcomes with unknown variance

References

• Dempster , A. P. , Laird , N. M. and Rubin , D. B. 1977 . Maximum likelihood from incomplete data via the EM algorithm (with discussion) . Journal of the Royal Statistical Society B , 39 : 1 – 38 .
   Google Scholar
• Fowlkes , E. B. 1979 . Some methods for studying the mixture of two normal (lognormal) distributions . Journal of the American Statistical Association , 74 : 561 – 575 .
   Web of Science ®Google Scholar
• Geller , N. L. and Pocock , S. J. 1987 . Interim analyses in randomized clinical trials: Ramifications and guidelines for practitioners . Biometrics , 43 : 213 – 223 .
   PubMed Web of Science ®Google Scholar
• Gould , A. L. 1992 . Interim analyses for monitoring clinical trials that do not affect the type I error rate . Statistics in Medicine , 11 : 55 – 66 .
   PubMed Web of Science ®Google Scholar
• Gould , A. L. and Pecore , V. J. 1982 . Group sequential methods for clinical trials allowing early acceptance of H0 and incorporating costs . Biometrika , 69 : 75 – 80 .
   Web of Science ®Google Scholar
• Lan , K. K. G. and De Mets , D. L. 1983 . Design and analysis of group sequential tests based on the Type 1 error spending rate function . Biometrika , 74 : 149 – 154 .
   Google Scholar
• Lohr , S. L. February 1988 . “ Accurate multivariate estimation using double and triple sampling ” . February , University of Minnesota Technical Report No. 505 .
   Google Scholar
• O ' Brien , P. C. and Fleming , T. R. 1979 . A mutiple testing procedure for clinical trials . Biometrics , 35 February : 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 February : 191 – 199 .
   Web of Science ®Google Scholar
• Pocock , S. J. 1982 . Interim analyses for randomized clinical trials: The group sequential approach . Biometrics , 38 February : 153 – 162 .
   PubMed Web of Science ®Google Scholar
• Rubin , D. B. 1976 . Inference and missing data . Biometrika , 63 February : 581 – 592 .
   Web of Science ®Google Scholar
• Stein , C. 1945 . A two-sample test for a linear hypothesis whose power is independent of the variance . Annals of Mathematical Statistics , 16 February : 243 – 258 .
   Google Scholar
• Wittes , J. and Brittain , E. 1990 . The role of internal pilot studies in increasing the efficiency of clinical trials . Statistics in Medicine , 9 February : 65 – 72 .
   PubMed Web of Science ®Google Scholar