Extension of adaptive alpha allocation methods for strong control of the family-wise error rate

Statistics in Medicine

Volumn 32, Issue 2, 2013, Pages 181-195

  Li, Haihong ^a   Sankoh, Abdul J ^a   D'Agostino, Ralph B ^b  

^a VERTEX PHARMACEUTICALS   (United States)

^b USA   (United States)

Author keywords

Clinical trials; Flexible alpha allocation scheme; Multiple comparisons; Multiple primary endpoints; Multiple secondary endpoints

Indexed keywords

ADAPTIVE ALPHA ALLOCATION APPROACH; ARTICLE; CLINICAL TRIAL (TOPIC); FAMILY WISE ERROR RATE; INTERMETHOD COMPARISON; POWER OF A TEST; PROBABILITY; STATISTICAL ANALYSIS; STATISTICAL DISTRIBUTION; STATISTICAL MODEL; STATISTICAL PARAMETERS; STATISTICAL SIGNIFICANCE; STUDY DESIGN; TREATMENT OUTCOME;

COMPUTER SIMULATION; ENDPOINT DETERMINATION; HUMANS; MODELS, STATISTICAL; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RESEARCH DESIGN;

EID: 84871325087     PISSN: 02776715     EISSN: 10970258     Source Type: Journal    
DOI: 10.1002/sim.5485     Document Type: Article

References (20)

1. D'Agostino RB. Controlling alpha in clinical trials: the case for secondary endpoints. Statistics in Medicine 2000; 19:762-766.
2. Moye LA.P-value interpretation and alpha allocation in clinical trials. Annals of Epidemiology 1998; 8:351-357.
3. Moye LA. Alpha calculus in clinical trials: considerations and commentary for the new millennium. Statistics in Medicine 2000; 19:767-779.
4. Dmitrienko A, Offen WW, Westfall PH. Gatekeeping strategies for clinical trials that do not require all primary effects to be significant. Statistics in Medicine 2003; 22:2387-2400.
5. Wiens BL.A fixed sequence Bonferroni procedure for testing multiple endpoints. Pharmaceutical Statistics 2003; 2:211-215.
6. Wiens BL, Dmitrienko A. The fallback procedure for evaluating a single family of hypotheses. Journal of Biopharmaceutical Statistics 2005; 15:929-942.
7. Li J, Mehrotra DV. An efficient method for accommodating potentially underpowered primary endpoints. Statistics in Medicine 2008; 27:5377-5391.
8. Zhao YD, Dmitrienko A, Tamura R. Design and analysis considerations in clinical trials with a sensitive subpopulation. Statistics in Biopharmaceutical Research 2010; 2:72-83.
9. Huque M, Alosh M.A flexible fixed-sequence testing method for hierarchically ordered correlated multiple endpoints in clinical trials. Journal of Statistical Planning and Inference 2008; 138:321-335.
10. Alosh M, Huque M.A flexible strategy for testing subgroups and overall population. Statistics in Medicine 2009; 28:3-23.
11. Dmitrienko A, Tamhane AC. Mixtures of multiple testing procedures for gatekeeping applications in clinical trials. Statistics in Medicine 2011; 30:1473-1488.
12. Fisher LD, Moye LA. Carvedilol and the food and drug administration approval process: an introduction. Controlled Clinical Trials 1999; 20:1-15.
13. Hochberg Y, Tamhane AC. Multiple Comparison Procedures. Wiley: New York, 1987.
14. Hochberg Y.A sharper Bonferroni procedure for multiple tests of significance. Biometrika 1988; 75:800-802.
15. Alosh M, Huque M.A consistency-adjusted alpha-adaptive strategy for sequential testing. Statistics in Medicine 2010; 29:1559-1571.
16. Li J, Mehrotra DV. Gatekeeping testing via adaptive alpha allocation. Biometrical Journal 2008; 50:704-715.
17. Sankoh AJ, D'Agostino RB, Huque MF. Efficacy endpoint selection and multiplicity adjustment methods in clinical trials with inherent multiple endpoint issues. Statistics in Medicine 2003; 22:3133-3150.
18. Offen W, Chuang-Stein C, Dmitrienko A, Littman G, Maca J, Meyerson L, Muirhead R, Stryszak P, Boddy A, Chen K, Copley-Merriman K, Dere W, Givens S, Hall D, Henry D, Jackson JD, Krishen A, Liu T, Ryder S, Sankoh AJ, Wang J, Yeh C. Multiple co-primary endpoints: medical and statistical solutions, a report from the multiple endpoints expert team of the pharmaceutical research and manufacturers of America. Drug Information Journal 2007; 41:31-46.
19. O'Neill RT. Commentary on 'Alpha calculus in clinical trials: considerations and commentary for the new millennium'. Statistics in Medicine 2000; 19:785-793.
20. Huque MF, Alosh M, Bhore R. Addressing multiplicity issues of a composite endpoint and its components in clincal trials. Journal of Biopharmaceutical Statistics 2011; 21:610-634.