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Multiplicity Issues in Clinical Trials 2010

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Full-day course taught by Frank Bretz and Alex Dmitrienko at a Société Francaise de Statistique (SFdS) meeting in Paris, France on October 14-15, 2010.

Back to Short Courses.

Textbook

Dmitrienko A, Tamhane A, Bretz F (editors). Multiple Testing Problems in Pharmaceutical Statistics. Chapman and Hall/CRC, 2009.

SAS programs

Download ZIP archive with R programs for Lectures 2, 7 and 8 in this course.

For more information on software implementation of commonly used multiple testing procedures and gatekeeping procedures, see Implementation of Multiple Testing Procedures and Implementation of Gatekeeping Procedures.

References

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Bretz, F., Maurer, W., Brannath, W., Posch, M. (2009). A graphical approach to sequentially rejective multiple test procedures. Statistics in Medicine. 28, 586-604.

Bretz, Maurer, Hommel (2010). Test and power considerations for multiple endpoint analyses using sequentially rejective graphical procedures. Statistics in Medicine (in press).

Burman, Sonesson, Guilbaud (2009). A recycling framework for the construction of Bonferroni-based multiple tests. Statistics in Medicine. 28, 739-761.

Dmitrienko, A., Kordzakhia, G., Tamhane, A.C. (2011). Multistage and mixture parallel gatekeeping procedures in clinical trials. Journal of Biopharmaceutical Statistics (in press).

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. See Dmitrienko Offen Westfall 2003.

Dmitrienko, A., Soulakova, J., Millen, B. (2011). Three methods for constructing parallel gatekeeping procedures in clinical trials. Journal of Biopharmaceutical Statistics (in press).

Dmitrienko, A., Tamhane, A.C. (2007). Gatekeeping procedures with clinical trial applications. Pharmaceutical Statistics. 6, 171-180. See Dmitrienko Tamhane 2007.

Dmitrienko, A., Tamhane, A.C. (2009). Gatekeeping procedures in clinical trials. Multiple Testing Problems in Pharmaceutical Statistics. Dmitrienko, A., Tamhane, A.C., Bretz, F. (editors). Chapman and Hall/CRC Press, New York. See Dmitrienko Tamhane 2009.

Dmitrienko, A., Tamhane, A.C. (2010). Mixtures of multiple testing procedures for gatekeeping applications in clinical trials. Statistics in Medicine (in press). See Dmitrienko Tamhane 2010.

Dmitrienko, A., Tamhane, A.C., Wiens, B.L. (2008). General multistage gatekeeping procedures. Biometrical Journal. 50, 667-677. See Dmitrienko Tamhane Wiens 2008.

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Hommel, G., Bretz, F. (2008). Aesthetics and power considerations in multiple testing - a contradiction? Biometrical Journal. 50, 657-666.

Hommel, G., Bretz, F., Maurer, W. (2007). Powerful short-cuts for multiple testing procedures with special reference to gatekeeping strategies. Statistics in Medicine. 26, 4063-4073.

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Hung, J., Wang, S.J. (2010). Challenges to multiple testing in clinical trials. Biometrical Journal (in press).

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Maurer, W., Hothorn, L. A., Lehmacher, W. (1995). Multiple comparisons in drug clinical trials and preclinical assays: a priori ordered hypotheses. Biometrie in der Chemisch-in-Pharmazeutischen Industrie. 6. Vollman, J. (editor). Fischer-Verlag, Stuttgart, 3-18.

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Rohmeyer (2010). gMCP: Graphical approach to multiple comparison procedures. R package on CRAN.

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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.

Sarkar, S.K. (1998). Some probability inequalities for censored MTP2 random variables: A proof of the Simes conjecture. The Annals of Statistics. 26, 494-504.

Simes, R.J. (1986). An improved Bonferroni procedure for multiple tests of significance. Biometrika. 63, 655-660.

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Strassburger, K., Bretz, F. (2008). Compatible simultaneous lower confidence bounds for the Holm procedure and other Bonferroni based closed tests. Statistics in Medicine. 27, 4914-4927.

Tamhane, A.C., Mehta, C., Liu, L. (2010) Testing a primary and a secondary endpoint in a group sequential design. Biometrics (in press).

Westfall, P. H., Krishen, A. (2001). Optimally weighted, fixed sequence, and gatekeeping multiple testing procedures. Journal of Statistical Planning and Inference. 99, 25-40.

Westfall, P.H., Bretz, F. (2010). Multiplicity in clinical trials. Encyclopedia of Biopharmaceutical Statistics (3rd edition). Chow, S.C. (editor), Marcel Dekker, New York.

Wiens, B. (2003). A fixed sequence Bonferroni procedure for testing multiple endpoints. Pharmaceutical Statistics. 2, 211-215.

Wiens, B., Dmitrienko, A. (2005). The fallback procedure for evaluating a single family of hypotheses. Journal of Biopharmaceutical Statistics. 15, 929-942.