Three Methods for Constructing Parallel Gatekeeping Procedures in Clinical Trials

REFERENCES

• Bauer , P. , Röhmel , J. , Maurer , W. , Hothorn , L. ( 1998 ). Testing strategies in multi-dose experiments including active control . Statistics in Medicine 17 : 2133 – 2146 .
   PubMed Web of Science ®Google Scholar
• Brechenmacher , T. , Xu , J. , Dmitrienko , A. , Tamhane , A. C. ( 2011 ). A mixture gatekeeping procedure based on the Hommel test for clinical trial applications . Journal of Biopharmaceutical Statistics 21 : 748 – 767 .
   PubMed Web of Science ®Google Scholar
• Bretz , F. , Maurer , W. , Brannath , W. , Posch , M. ( 2009 ). A graphical approach to sequentially rejective multiple test procedures . Statistics in Medicine 28 : 586 – 604 .
   PubMed Web of Science ®Google Scholar
• Burman , C.-F. , Sonesson , C. , Guilbaud , O. ( 2009 ). A recycling framework for the construction of Bonferroni-based multiple tests . Statistics in Medicine 28 : 739 – 761 .
   PubMed Web of Science ®Google Scholar
• Dmitrienko , A. , Tamhane , A. C. ( 2009 ). Gatekeeping procedures in clinical trials . In: Dmitrienko , A. , Tamhane , A. C. , Bretz , F. , eds. Multiple Testing Problems in Pharmaceutical Statistics . New York : Chapman and Hall/CRC Press .
   Google Scholar
• Dmitrienko , A. , Tamhane , A. C. ( 2011 ). Mixtures of multiple testing procedures for gatekeeping applications in clinical trials. Statistics in Medicine, in press .
   Google Scholar
• Dmitrienko , A. , Kordzakhia , G. , Tamhane , A. C. (2011). Multistage and mixture gatekeeping procedures in clinical trials. Journal of Biopharmaceutical Statistics 21:726–747.
   PubMed Web of Science ®Google Scholar
• Dmitrienko , A. , Offen , W. W. , Westfall , P. H. ( 2003 ). Gatekeeping strategies for clinical trials that do not require all primary effects to be significant . Statistics in Medicine 22 : 2387 – 2400 .
   PubMed Web of Science ®Google Scholar
• Dmitrienko , A. , Tamhane , A. C. , Wang , X. , Chen , X. ( 2006 ). Stepwise gatekeeping procedures in clinical trial applications . Biometrical Journal 48 : 984 – 991 .
   PubMed Web of Science ®Google Scholar
• Dmitrienko , A. , Tamhane , A. C. , Liu , L. , Wiens , B. L. ( 2008a ). A note on tree gatekeeping procedures in clinical trials . Statistics in Medicine 27 : 3446 – 3451 .
   PubMed Web of Science ®Google Scholar
• Dmitrienko , A. , Tamhane , A. C. , Wiens , B. L. ( 2008b ). General multistage gatekeeping procedures . Biometrical Journal 50 : 667 – 677 .
   PubMed Web of Science ®Google Scholar
• Dmitrienko , A. , Wiens , B. L. , Tamhane , A. C. , Wang , X. ( 2007 ). Tree-structured gatekeeping tests in clinical trials with hierarchically ordered multiple objectives . Statistics in Medicine 26 : 2465 – 2478 .
   PubMed Web of Science ®Google Scholar
• Guilbaud , O. ( 2007 ). Bonferroni parallel gatekeeping—Transparent generalizations, adjusted p values, and short direct proofs . Biometrical Journal 49 : 917 – 927 .
   PubMedGoogle Scholar
• Li , J. , Mehrotra , D. ( 2008a ). An efficient method for accommodating potentially underpowered primary endpoints . Statistics in Medicine 27 : 5377 – 5391 .
   PubMed Web of Science ®Google Scholar
• Li , J. , Mehrotra , D. ( 2008b ). Gatekeeping testing via adaptive alpha allocation . Biometrical Journal 50 : 704 – 715 .
   PubMed Web of Science ®Google Scholar
• Maurer , W. , Hothorn , L. A. , Lehmacher , W. ( 1995 ). Multiple comparisons in drug clinical trials and preclinical assays: a priori ordered hypotheses . In: Vollman , J. , ed. Biometrie in der Chemisch-in-Pharmazeutischen Industrie 6. Stuttgart : Fischer-Verlag , pp. 3 – 18 .
   Google Scholar
• Millen , B. A. , Dmitrienko , A. ( 2011 ). Chain procedures: A class of flexible closed testing procedures with clinical trial applications . Statistics in Biopharmaceutical Research 3 : 14 – 30 .
   Web of Science ®Google Scholar
• O'Neill , R. T. ( 1997 ). Secondary endpoints cannot be validly analyzed if the primary endpoint does not demonstrate clear statistical significance . Controlled Clinical Trials 18 : 550 – 556 .
   PubMedGoogle Scholar
• Roth , A. J. ( 1999 ). Multiple comparison procedures for discrete test statistics . Journal of Statistical Planning and Inference 82 : 101 – 117 .
   Web of Science ®Google Scholar
• Sarkar , S. K. ( 1998 ). Some probability inequalities for censored MTP2 random variables: A proof of the Simes conjecture . Annals of Statistics 26 : 494 – 504 .
   Web of Science ®Google Scholar
• Sarkar , S. , Chang , C. K. ( 1997 ). Simes' method for multiple hypothesis testing with positively dependent test statistics . Journal of the American Statistical Association 92 : 1601 – 1608 .
   Web of Science ®Google Scholar
• Westfall , P. H. , Krishen , A. ( 2001 ). Optimally weighted, fixed sequence, and gatekeeping multiple testing procedures . Journal of Statistical Planning and Inference 99 : 25 – 40 .
   Web of Science ®Google Scholar