Sample Size Re-Estimation for Adaptive Sequential Design in Clinical Trials

REFERENCES

• Chen , Y. H. J. , DeMets , D. L. , Lan , K. K. G. ( 2004 ). Increasing the sample size when the unblinded interim result is promising . Stat. Med. 23 : 1023 – 1038 .
   PubMed Web of Science ®Google Scholar
• Chung , K. L. ( 1982 ). Lectures From Markov Processes to Brownian Motion . New York : Springer-Verlag .
   Google Scholar
• Cui , L. , Hung , H. M. , Wang , S. J. ( 1999 ). Modification of sample size in group sequential clinical trials . Biometrics 55 : 853 – 857 .
   PubMed Web of Science ®Google Scholar
• Fisher , L. D. ( 1998 ). Self-designing clinical trials . Stat. Med. 17 : 1551 – 1562 .
   PubMed Web of Science ®Google Scholar
• Fleming , T. R. ( 2006 ). Standard versus adaptive monitoring procedures: A commentary . Stat. Med. 25 : 3305 – 3312 .
   PubMed Web of Science ®Google Scholar
• Jennison , C. , Turnbull , B. W. ( 2000 ). Group Sequential Methods with Applications to Clinical Trials . Boca Raton, FL : Chapman & Hall/CRC .
   Google Scholar
• Jennison , C. , Turnbull , B. W. ( 2003 ). Mid-course sample size modification in clinical trials based on the observed treatment effect . Stat. Med. 22 : 971 – 993 .
   PubMed Web of Science ®Google Scholar
• Lan , K. K. G. , DeMets , D. L. ( 1983 ). Discrete sequential boundaries for clinical trials . Biometrika 70 : 659 – 663 .
   Web of Science ®Google Scholar
• Liu , G. F. , Zhu , G. R. , Cui , L. ( 2008 ). Evaluating the adaptive performance of flexible sample size designs with treatment difference in an interval . Stat. Med. 27 : 584 – 596 .
   PubMed Web of Science ®Google Scholar
• Moyé , L. A. ( 2006 ). Statistical Monitoring of Clinical Trials . New York : Springer .
   Google Scholar
• Müller , H. H. , Schäfer , H. ( 2001 ). Adaptive group sequential designs for clinical trials: Combining the advantages of adaptive and of classical group sequential approaches . Biometrics 57 : 886 – 891 .
   PubMed Web of Science ®Google Scholar
• Müller , H. H. , Schäfer , H. ( 2004 ). A general statistical principle for changing a design any time during the course of a trial . Stat. Med. 23 : 2497 – 2508 .
   PubMed Web of Science ®Google Scholar
• O'Brien , P. C. , Fleming , T. R. ( 1979 ). A multiple testing procedure for clinical trials . Biometrics 35 : 549 – 556 .
   PubMed Web of Science ®Google Scholar
• Proschan , M. A. , Hunsberger , S. A. ( 1995 ). Designed extension of studies based on conditional power . Biometrics 51 : 1315 – 1324 .
   PubMed Web of Science ®Google Scholar
• Tsiatis , A. A. , Rosner , G. L. , Mehta , C. R. ( 1984 ). Exact confidence intervals following a group sequential test . Biometrics 40 : 797 – 803 .
   PubMed Web of Science ®Google Scholar
• Whitehead , J. ( 1997 ). The Design and Analysis of Sequential Clinical Trials , 2nd ed. . West Sussex, England : John Wiley & Sons Ltd .
   Google Scholar