A consistency-adjusted strategy for accommodating an underpowered primary endpoint

Journal of Biopharmaceutical Statistics

Volumn 22, Issue 1, 2012, Pages 160-179

  Huque, Mohammad F ^a,b   Alosh, Mohamed ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^b GEORGIA SOUTHERN UNIVERSITY   (United States)

Author keywords

Composite endpoint; Consistency adjusted testing strategy; Multiple testing; Subgroup analysis; Underpowered primary endpoint

Indexed keywords

ARTICLE; CLINICAL TRIAL (TOPIC); DRUG EFFICACY; INTERMETHOD COMPARISON; MATHEMATICAL COMPUTING; PRIMARY ENDPOINT; PRIORITY JOURNAL; RELIABILITY; SECONDARY ENDPOINT;

CLINICAL TRIALS AS TOPIC; DECISION SUPPORT TECHNIQUES; ENDPOINT DETERMINATION; HUMANS;

EID: 84856287503     PISSN: 10543406     EISSN: 15205711     Source Type: Journal    
DOI: 10.1080/10543406.2010.513464     Document Type: Article

References (18)

1. Alosh, M., Huque, M. F. (2009). A flexible strategy for testing subgroups and overall population. Statistics in Medicine 28: 3-23.
2. Alosh, M., Huque, M. F. (2007). A flexible strategy for testing subgroups and overall populations. In: Proceedings of the Joint Statistical Meetings, Salt Lake City, UT.
3. Bretz, F., Maurer, W., Brannath, W., Posch, M. (2009). A graphical approach to sequentially rejective multiple test procedures. Statistics in Medicine 28: 586-604.
4. Dormandy, J., et al. on behalf of the PROactive investigators. (2005). Secondary prevention of macrovascular events in patients with type 2 diabetes in the PROactive study (PROspective pioglitazone clinical trials in macrovascular events): A randomized controlled trial. Lancet 366: 1279-1289. (Pubitemid 41416583)
5. Fisher, L. D., Moyé, L. A. (1999). Carvedilol and the food and drug administration approval process. Controlled Clinical Trials 20: 16-39.
6. Huque, M. F., Alosh, M. (2008). A flexible fixed-sequence testing method for hierarchically ordered correlated multiple endpoints in clinical trials. Journal of Statistical Planning and Inference 138: 321-335.
7. Li, J., Mehrotra, D. (2008). An efficient method for accommodating potentially underpowered primary endpoints. Statistics in Medicine 27: 5377-5391.
8. Moyé, L. (2000). Alpha calculus in clinical trials. Consideration and commentary for the new millennium. Statistics in Medicine 19: 767-779.
9. Moyé, L. A. (2003). Multiple Analyses in Clinical Trials: Fundamentals for Investigators. New York, Inc: Springer-Verlag.
10. Moyé, L. A., Baraniuk, S. (2007). Dependence, hyper-dependence and hypothesis testing in clinical trials. Contemporary Clinical Trials 28: 68-78. (Pubitemid 44780203)
11. Packer, M., Bristow, M. R., et al. (1996). The effect of carvedilol of morbidity and mortality in patients with chronic heart failure. New England Journal of Medicine 334: 1349-1355. (Pubitemid 26152713)
12. Packer, M., et al. (1999). Comparative effects of low and high doses of the angiotensin-converting enzyme inhibitor, lisinopril, on morbidity and mortality in chronic heart failure. Circulation 100: 2318-2319.
13. Sankoh, A. J., D'Agostino, R. B., Huque, M. F. (2003). Efficacy endpoint selection and multiplicity adjustment methods in clinical trials with inherent multiple issues. Statistics in Medicine 22: 3133-3150. (Pubitemid 37220623)
14. (R) 9.2 Language Reference. Cary, NC: SAS Institute, Inc.
15. Song, Y., Chi, G. Y. (2007). A method for testing a prespecified subgroup in clinical trials. Statistics in Medicine 26: 3535-3549. (Pubitemid 47180696)
16. Wiens, B. L. (2003). A fixed sequence Bonferroni procedure for testing multiple endpoints. Pharmaceutical. Statistics 2: 211-215.
17. Wiens, B. L., Dmitrienko, A. (2005). The fallback procedure for evaluating a single family of hypotheses. J. Biopharmaceutical Statistics 15: 929-942. (Pubitemid 41540979)
18. Wilcox, R., Bousser, M.-G., Betteridge, D. J., Guntram, S., Pirags, V., Kupfer, S., Dromandy, J. (2007). Effects of Pioglitazone in patients with or without previous stroke. Stroke 38: 865-873.