Multiple Testing Problems in Pharmaceutical Statistics 2008
Half-day course taught by Alex Dmitrienko (Eli Lilly and Company) at the FDA/Industry Statistics Workshop in Crystal City, VA on September 15, 2008.
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Dmitrienko A, Molenberghs G, Chuang-Stein C, Offen W. Analysis of Clinical Trials Using SAS. SAS Press, 2005.
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.
Anderson et al. (1999). Randomized secondary prevention trial of azithromycin in patients with coronary artery disease and serological evidence for chlamydia pneumoniae infection: Azithromycin in coronary artery disease: elimination of myocardial infection with chlamydia (ACADEMIC) study. Circulation. 99, 1540-1547.
CPMP Points to Consider. Multiplicity issues in clinical trials. CPMP/EWP/908/99 (Sep 19, 2002).
Dahlöf B, et al. (2002). Cardiovascular morbidity and mortality in the Losartan Intervention For Endpoint reduction in hypertension study (LIFE): a randomised trial against atenolol. Lancet. 359, 995–1003.
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.
Dunnett C. (1955). A multiple comparison procedure for comparing several treatments with a control. Journal of the American Statistical Association. 50, 1096-1121.
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.
Holm S. (1979). A simple sequentially rejective multiple test procedure. Scandinavian Journal of Statistics. 6, 65-70.
Hochberg Y. (1988). A sharper Bonferroni procedure for multiple significance testing. Biometrika. 75, 800-802.
Hommel G. (1988). A stagewise rejective multiple test procedure based on a modified Bonferroni test. Biometrika. 75, 383-386.
Hsu J, Berger R. (1999). Stepwise confidence intervals without multiplicity adjustment for dose-response and toxicity studies. Journal of the American Statistical Association. 94, 468-482.
Keystone et al. (2004). Radiographic, clinical, and functional outcomes of treatment with adalimumab (a human anti-tumor necrosis factor monoclonal antibody) in patients with active rheumatoid arthritis receiving concomitant methotrexate therapy. Arthritis and Rheumatism. 50, 1400-1411.
Marcus R, Peritz E, Gabriel K. (1976). On closed testing procedure with special reference to ordered analysis of variance. Biometrika. 63, 655-660.
Naik U. (1975). Some selection rules for comparing p processes with a standard. Communications in Statistics. Series A. 4, 519-535.
Maurer W, Hothorn L, Lehmacher W. (1995). Multiple comparisons in drug clinical trials and preclinical assays: a-priori ordered hypotheses. In Biometrie in der chemisch-pharmazeutischen Industrie. Vollmar J (Editor). Stuttgart: Fischer Verlag. 6, 3-18.
Petri M, et al. (2004). Effects of prasterone on disease activity and symptoms in women with active systemic lupus erythematosus. Arthritis and Rheumatism. 50, 2858-2868.
Simon L, et al. (1999). Anti-inflammatory and upper gastrointestinal effects of celecoxib in rheumatoid arthritis. Journal of American Medical Association. 282, 1921-1928.
Schulz K, Grimes D. (2005). Multiplicity in randomised trials II: subgroup and interim analyses. Lancet. 365, 1657-1661.
Steel R. (1959). A multiple comparison sign test: Treatments versus control. Journal of the American Statistical Association. 54, 767-775.
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.
Westfall P, Tobias R, Rom D, Wolfinger R, Hochberg Y. (1999). Multiple Comparisons and Multiple Tests Using the SAS System. Cary, NC: SAS Institute, Inc.
Westfall P, Krishen A. (2001). Optimally weighted, fixed sequence and gatekeeper multiple testing procedures. Journal of Statistical Planning and Inference. 99, 25-41.
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.