Multiple testing procedures in two pivotal clinical trials for approval of a new pharmaceutical product

Journal of Biopharmaceutical Statistics

Volumn 21, Issue 4, 2011, Pages 669-681

  Wiens, Brian L ^a  

^a ALCON RESEARCH LTD   (United States)

Author keywords

Closed testing procedure; Fallback; Fixed sequence; Weighted test

Indexed keywords

ALTERNATIVE HYPOTHESIS; ARTICLE; CLINICAL TRIAL (TOPIC); CLOSED TESTING; CONTROLLED STUDY; DRUG APPROVAL; FALLBACK PROCEDURE; INTERMETHOD COMPARISON; INTERNAL CONSISTENCY; NULL HYPOTHESIS; PRIORITY JOURNAL; SIMULATION; STATISTICAL ANALYSIS; WEIGHTED HOLM;

CLINICAL TRIALS AS TOPIC; COMPUTER SIMULATION; DATA INTERPRETATION, STATISTICAL; DRUG APPROVAL; MODELS, STATISTICAL; PHARMACEUTICAL PREPARATIONS; PROBABILITY;

EID: 79957480089     PISSN: 10543406     EISSN: 15205711     Source Type: Journal    
DOI: 10.1080/10543406.2011.551330     Document Type: Article

References (15)

1. Dmitrienko, A., Tamhane, A. C., Bretz, F. (2009). Multiple Testing Problems in Pharmaceutical Statistics. New York: Chapman & Hall/CRC Press.
2. Food and Drug Administration. (1998). Guidance for Industry: Providing Clinical Evidence of Effectiveness for Human Drugs and Biological Products. Washington, DC: U.S. Department of Health and Human Services.
3. Grechanovsky, E., Hochberg, Y. (1999). Closed testing procedures are better and often admit a shortcut. Journal of Statistical Planning and Inference 76(1-2):79-91. doi: 10.1016/S0378-3758(98)00125-6.
4. Hochberg, Y. (1988). A sharper Bonferroni procedure for multiple tests of significance. Biometrika 75(4):800-802. doi: 10.1093/biomet/75.4.800.
5. Hochberg, Y., Tamhane, A. C. (1987). Multiple Comparisons Procedures. New York: Wiley.
6. Holm, S. (1979). A simple sequentially rejective multiple test procedure. Scandinavian Journal of Statistics 6:65-70.
7. Hommel, G. (1988). A stagewise rejective multiple test procedure based on a modified Bonferroni test. Biometrika 75:383-386.
8. Hommel, G., Bretz, F. (2008). Aesthetics and power considerations in multiple testing: A contradiction? Biometrical Journal 50(5):657-6668. DOI 10.1002/bmj.200710463.
9. International Conference on Harmonisation. (1998). Statistical Principles for Clinical Trials, E9. Geneva, Switzerland: International Conference on the Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.
10. Marcus, R., Peritz, E., Gabriel, K. R. (1976). On closed testing procedures with special reference to ordered analysis of variance. Biometrika 63(3):655-660.
11. Simes, R. J. (1986). An improved Bonferroni procedure for multiple tests of significance. Biometrika. 73:751-754.
12. Westfall, P. J., Krishen, A. (2001). Optimally weighted, fixed sequence and gatekeeper multiple testing procedures. Journal of Statistical Planning and Inference 99(1):25-40. DOI: 10.1016/S0378-3758(01)00077-5. (Pubitemid 33619467)
13. Wiens, B. L. (2003). A fixed sequence Bonferroni procedure for testing multiple endpoints. Pharmaceutical Statistics 2(3):211-215.
14. Wiens, B. L., Dmitrienko, A. (2005). The fallback procedure for evaluating a single family of hypotheses. Journal of Biopharmaceutical Statistics. 15(6):929-942. (Pubitemid 41540979)
15. Wiens, B. L., Dmitrienko, A. (2010). On selecting a multiple comparisons procedure for analysis of a clinical trial: Fallback, fixed sequence and related procedures. Statistics in Biopharmaceutical Research 2(1):22-32. DOI: 10.1198/sbr.2010.08035.