Analysis strategies for adaptive designs with multiple endpoints

Journal of Biopharmaceutical Statistics

Volumn 17, Issue 6, 2007, Pages 1189-1200

  Chang, Mark ^a   Chow, Shein Chung ^b  

^a MILLENNIUM PHARMACEUTICALS INC   (United States)

^b DUKE UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

Adaptive design with multiple endpoints; Closed testing procedure; Fractal gatekeeper procedure; Gatekeeper procedure; Multiplicity

Indexed keywords

CLINICAL PRACTICE; CLINICAL RESEARCH; CONFERENCE PAPER; FRACTAL ANALYSIS; MATHEMATICAL ANALYSIS; MEDICAL ERROR; PRIORITY JOURNAL; STATISTICAL ANALYSIS;

CLINICAL TRIALS AS TOPIC; ENDPOINT DETERMINATION; HUMANS; RESEARCH DESIGN;

EID: 36248997141     PISSN: 10543406     EISSN: 15205711     Source Type: Journal    
DOI: 10.1080/10543400701645348     Document Type: Conference Paper

References (17)

1. Bauer, P., Röhmel, J., Maurer, W., Hothorn, L. (1998). Testing strategies in multi-dose experiments including active control. Statistics in Medicine 17:2133-2146.
2. Chang, M. (2007a). Adaptive Design Theory and Implementation Using SAS and R. New York: Taylor & Francis Group, Chapman & Hall/CRC.
3. Chang, M. (2007b). Adaptive design method based on sum of p-values. Statistics in Medicine 26:2772-2784.
4. 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.
5. Dmitrienko, A. et al. (2005). Analysis of Clinical Trials Using SAS. Cary, North Carolina: SAS Institute Inc.
6. 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.
7. Hochberg, Y. (1988). A sharper Bonferroni's procedure for multiple tests of significance. Biometrika 75:800-803.
8. Holm, S. (1979). A simple sequentially rejective multiple test procedure. Scand. J. Statist. 6:65-70.
9. Hommel, G. (1988). A stage-wise rejective multiple test procedure based on a modified Bonferroni test. Biometrika 75:383-386.
10. Kieser, M., Bauer, P., Lehmacher, W. (1999). Inference on multiple endpoints in clinical trials with adaptive interim analyses. Biometrical Journal 41:261-277.
11. Marcus, R., Peritz, E., Gabriel, K. R. (1976). On closed testing procedures with special reference to ordered analysis of variance. Biometrika 63:655-660.
12. Moyé, L. A. (2003). Multiple Analysis in Clinical Trials. New York: Springer-Verlag.
13. O'Neill, R. T. (1997). The primary endpoint does not demonstrate clear statistical significance. Controlled Clinical Trials 18:550-556.
14. Rom, D. M. (1990). A sequentially rejective test procedure based on a modified Bonferroni inequality. Biometrika 77:663-665.
15. Tang, D., Geller, N. L. (1999). Closed testing procedures for group sequential clinical trials with multiple endpoints. Biometrics 55:1188-1192.
16. Westfall, P. H., Krishen, A. (2001). Optimally weighted, fixed sequence, and gatekeeper multiple testing procedures. Journal of Statistical Planning and Inference 99:25-41.
17. Westfall, P. H. et al. (1999). Multiple Comparisons and Multiple Tests. Cary, North Carolina: SAS Institute Inc.