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Analysis of Multiple Endpoints 2007

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Half-day course taught by Alex Dmitrienko (Eli Lilly and Company) at the 5th International Conference on Multiple Comparison Procedures in Vienna, Austria on July 8, 2007

Back to Short Courses.

Textbook

Dmitrienko A, Molenberghs G, Chuang-Stein C, Offen W. Analysis of Clinical Trials Using SAS. SAS Press, 2005.

Module A

References

Dahlöf 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.

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.

Petri 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 et al. (1999). Anti-inflammatory and upper gastrointestinal effects of celecoxib in rheumatoid arthritis. Journal of American Medical Association. 282, 1921-1928.

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.

CPMP Points to Consider. Multiplicity issues in clinical trials.

Module B

References

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.

Dahlöf 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.

Dallow, Leonov, Roger. (2006). O'Brien's OLS and GLS statistics in clinical trials: multivariate approach. GlaxoSmithKline BDS Technical Report 2006-03.

Lauter. (1996). Exact t and F tests for analyzing studies with multiple endpoints. Biometrics. 52, 964-970. Lehmacher, Wassmer, Reitmeir. (1991). Procedures for two-sample comparison with multiple endpoints controlling the experimentwise error rate. Biometrics. 47, 511-521.

Logan, Tamhane. (2004). On O'Brien's OLS and GLS tests for multiple endpoints. In: Benjamini, Bretz, Sarkar. (Eds). Recent Developments in Multiple Comparison Procedures. IMS Lecture Notes - Monograph Series. 47, 76-88.

Marcus, Peritz, Gabriel. (1976). On closed testing procedure with special reference to ordered analysis of variance. Biometrika. 63, 655-660.

O'Brien. (1984). Procedures for comparing samples with multiple endpoints. Biometrics. 40, 1079-1087.

Perlman (1969). One-sided testing problems in multivariate anal- ysis. Annals of Mathematical Statistics. 40, 549-567.

Tang, Geller, Pocock. (1993). On the design and analysis of randomized clinical trials with multiple endpoints. Biometrics. 49, 23-30.

Tang (1994). Uniformly more powerful tests in a one-sided mul- tivariate problem. Journal of the American Statistical Association. 89, 380-386.

Wang, McDermott. (1998). Conditional likelihood ratio test for a non-negative normal mean vector. Journal of the American Statistical Association. 93, 380-386.

Westfall, Young. (1993). Resampling-Based Multiple Testing: Examples and Methods for P-Value Adjustment. New York:John Wiley.

Westfall, Tobias, Rom, Wolfinger, Hochberg. (1999). Multiple Comparisons and Multiple Tests Using the SAS System. Cary, NC: SAS Institute, Inc.

Rheumatoid arthritis trial example

Download RA data set

Download GlobTest macro

For more information about the rheumatoid arthritis trial example and implementation of popular global tests, see Analysis of Clinical Trials Using SAS (Section 2.6).

Module C

References

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

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

Dmitrienko, Tamhane, Wiens. (2007). General multi-stage gatekeeping procedures. Northwestern University. Department of Industrial Engineering and Management Sciences. Working Paper No. 07-06. Download.

Maurer, Hothorn, Lehmacher. (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.

Westfall, Krishen. (2001). Optimally weighted, fixed sequence and gatekeeper multiple testing procedures. Journal of Statistical Planning and Inference. 99, 25-41.

More information

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.