A flexible strategy for testing subgroups and overall population

Statistics in Medicine

Volumn 28, Issue 1, 2009, Pages 3-23

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

^a OTS   (United States)

^b OTS   (United States)

^c GEORGIA SOUTHERN UNIVERSITY   (United States)

Author keywords

Dependence; Significance levels for the subgroup analysis; Study power; Subgroup analysis

Indexed keywords

DOXORUBICIN; FLUOROURACIL; FOLINIC ACID; OXALIPLATIN; PIOGLITAZONE; TOPOTECAN;

ACCURACY; ARTICLE; CANCER COMBINATION CHEMOTHERAPY; CANCER SURVIVAL; CASE STUDY; COLON CANCER; CONDYLOMA ACUMINATUM; DISEASE FREE SURVIVAL; DRUG DOSE TITRATION; DRUG EFFICACY; MEDICAL RESEARCH; NON INSULIN DEPENDENT DIABETES MELLITUS; OVARY CANCER; POPULATION RESEARCH; POWER OF A TEST; STATISTICAL MODEL; TEST RETEST RELIABILITY; TREATMENT RESPONSE;

CLINICAL TRIALS AS TOPIC; CONDYLOMATA ACUMINATA; DATA INTERPRETATION, STATISTICAL; HUMANS; MODELS, STATISTICAL; RESEARCH DESIGN; SAMPLE SIZE; TREATMENT OUTCOME;

EID: 61749083299     PISSN: 02776715     EISSN: 10970258     Source Type: Journal    
DOI: 10.1002/sim.3461     Document Type: Article

References (21)

1. Moyé LA. Trials within trials: confirmatory subgroup analyses in controlled clinical experiments. Controlled Clinical Trials 2001; 22:605-619.
2. Pocock SJ, Assmann SE, Enos LE, Kasten LE. Subgroup analysis, covariate adjustment and baseline comparison in clinical trial reporting: current practice and problems. Statistics in Medicine 2002; 21:2917-2930.
3. Yusuf S, Wittes J, Probstfield J, Tyroler H. Analysis sand interpretation of treatment effect in subgroups of patients in randomized clinical trials. Journal of the American Medical Association 1991; 266:93-98.
4. Biesheuvel EHE, Hothron L. Protocol designed subgroup analyses in multiarmed clinical trials: multiplicity aspects. Journal of Biopharmaceutical Statistics 2003; 13:663-673.
5. Moyé LA. Multiple Analyses in Clinical Trials: Fundamentals for Investigators. Springer: New York, 2003.
6. Song Y, Chi GY. A method for testing a prespecified subgroup in clinical trials. Statistics in Medicine 2007; 26:3535-3549.
7. Proschan M, Waclawiw M. Practical guidelines for multiplicity adjustment in clinical trials. Controlled Clinical Trials 2000; 21:527-539.
8. CPMP. Points to Consider on Multiplicity Issues in Clinical Trials (CPMP/EWP/908/99). EMEA: London, 2002.
9. Wiens BL. A fixed sequence Bonferroni procedure for testing multiple endpoints. Pharmaceutical Statistics 2003; 2:211-215.
10. Wiens BL, Dmitrienko A. The fallback procedure for evaluating a single family of hypotheses. Journal of Biopharmaceutical Statistics 2005; 15:929-942.
11. Huque MF, 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.
12. Moyé LA, Baraniuk S. Dependence, hyper-dependence and hypothesis testing in clinical trials. Contemporary Clinical Trials 2007; 28:68-78.
13. Pinheiro J, Bornkamp B, Bretz F. Design and analysis of dose-finding studies combining multiple comparisons and modeling procedures. Journal of Biopharmaceutical Statistics 2006; 16:639-656.
14. Moyé L. Alpha calculus in clinical trials. Consideration and commentary for the new millennium. Statistics in Medicine 2000; 19:767-779.
15. Koch GG. Discussion of p-value adjustments for sub-group analyses. Journal of Biopharmaceutical Statistics 1997; 7:323-331.
16. Grouin J, Coste M, Lewis J. Subgroup analysis in randomized clinical trials: statistical and regulatory issues. Journal of Biopharmaceutical Statistics 2005; 15:869-882.
17. (R) 9.2 Language Reference, SAS Institute Inc., Cary, NC.
18. DeGramont A, Boni C, Navarro M, Tabernero J, Hickish T, Topham C, Bonetti A, Clingan P, Marceau-Suissa J, Lorenzato C, André T. Oxaliplatin/5fu/lv in the adjuvant treatment of stage II and stage III colon cancer: efficacy results with a median follow-up 4 years. American Society of Clinical Oncology (ASCO) Annual Meeting, 2005; abstract 3501.
19. Gordon AN, Tonda M, Sun S, Rackoff W. Long-term survival advantage for women treated with pegylated liposomal doxorubicin compared with topotecan in a phase 3 randomized study of recurrent and refractory epithelial ovarian cancer. Gynecologic Oncology 2004; 95:1-8.
20. Dormandy J et al. On behalf of the PROactive investigators, 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 2005; 366:1279-1289.
21. Wilcox R, Bousser M-G, Betteridge DJ, Guntram S, Pirags V, Kupfer S, Dromandy J. Effects of Pioglitazone in patients with or without previous stroke. Stroke 2007; 38:865-873.