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Half-day course taught by Alex Dmitrienko (Eli Lilly and Company) at the FDA/Industry Statistics Workshop on Sep 15, 2008.

Alex Dmitrienko, Geert Molenberghs, Christy Chuang-Stein, Walt Offen. Analysis of Clinical Trials Using SAS: A Practical Guide. SAS Press, 2005.

This macro computes adjusted p-values for the fallback test [Download].

This macro implements the O'Brien OLS, GLS and rank-sum tests [Download].

This macro performs sample size calculations in studies with two arms based on the O'Brien OLS and GLS tests [Download].

This macro performs inferences for individual endpoints after a significant global test using the O'Brien OLS, GLS and rank-sum tests [Download].

This macro implements Bonferroni-based parallel gatekeeping procedures [Download].

This macro implements Bonferroni-based tree gatekeeping procedures [Download].

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CPMP Points to Consider. Multiplicity issues in clinical trials. CPMP/EWP/908/99 (Sep 19, 2002).

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Dmitrienko A, Offen W, Westfall P. (2003). Gatekeeping strategies for clinical trials that do not require all primary effects to be significant. Statistics in Medicine. 22, 2387-2400.

Dmitrienko A, Molenberghs A, Christy C, Offen W. (2005). Analysis of Clinical Trials Using SAS: A Practical Guide. SAS Press.

Dmitrienko A, Tamhane A, Wang X, Chen X. (2006). Stepwise gatekeeping procedures in clinical trial applications. Biometrical Journal. 48, 984-991.

Dmitrienko A, Fritsch K, Hsu J, Ruberg S. (2007). Design and analysis of dose-ranging clinical studies. Pharmaceutical Statistics Using SAS: A Practical Guide. Dmitrienko A, Chuang-Stein C, D'Agostino R. (editors). SAS Press: Cary, NC.

Dmitrienko A, Wiens B, Tamhane A, Wang X. (2007). Tree-structured gatekeeping tests in clinical trials with hierarchically ordered multiple objectives. Statistics in Medicine. 26, 2465-2478.

Dmitrienko A, Tamhane A, Wiens B. (2008). General multistage gatekeeping procedures. Biometrical Journal. In press.

Dmitrienko A, Tamhane A, Liu L, Wiens B. (2008). A note on tree gatekeeping procedures in clinical trials. Statistics in Medicine. 27, 3446-3451.

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FDA guidance. Systemic Lupus Erythematosus — Developing Drugs for Treatment.

FDA guidance. Clinical Studies Section of Labeling for Prescription Drug and Biological Products - Content and Format.

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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. In press.

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