Stratified experiments reexamined with emphasis on multicenter trials

Controlled Clinical Trials

Volumn 24, Issue 2, 2003, Pages 167-181

  Ganju, Jitendra ^a   Mehrotra, Devan V ^b  

^a NOVARTIS PHARMA AG   (Switzerland)

^b MERCK RESEARCH LABORATORIES   (United States)

Author keywords

Interaction; Random stratum sizes; Weighting

Indexed keywords

ANALYTIC METHOD; ARTICLE; EMPIRICISM; METHODOLOGY; MULTICENTER STUDY; SAMPLE SIZE; SIMULATION; VALIDATION PROCESS;

EID: 0037385334     PISSN: 01972456     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0197-2456(02)00305-7     Document Type: Article

References (18)

1. Cox D.R. Interaction. International Statistical Review. 52:1984;1-31.
2. Gould A.L. Multi-centre trial analysis revisited. Stat Med. 17:1998;1779-1797.
3. ICH Harmonised Tripartite Guideline Statistical principles for clinical trials. Stat Med. 18:1999;1905-1942.
4. Fleiss J.L. Analysis of data from multiclinic trials. Control Clin Trials. 7:1986;267-275.
5. Yates F. The analysis of multiple classification with unequal numbers in different classes. J Am Stat Assoc. 29:1934;51-66.
6. Yates F. The technique of analysis of variance. Nature. 27:1947;472-473.
7. Searle S.R. Linear models for unbalanced data. 1987;Wiley, New York.
8. Nelder J.A. A reformulation of linear models (with discussion). J R Stat Soc Ser A. 140:1977;48-76.
9. Nelder J.A. The statistics of linear models. back to basics Statistical Computing. 4:1994;221-234.
10. Fleiss J.L. The design and analysis of clinical experiments. 1986;Wiley, New York.
11. Senn S. Some controversies in planning and analysing multicentre trials. Stat Med. 17:1998;1753-1765.
12. Senn S. Consensus and controversy in pharmaceutical statistics (with discussion). The Statistician. 49:2000;135-176.
13. Lin Z. An issue of statistical analysis in controlled multicentre studies. how shall we weight the centres? Stat Med. 18:1999;365-373.
14. Gallo P. Center-weighting issues in multicenter clinical trials. J Biopharm Stat. 10:2000;145-163.
15. Schwemer G. General linear models for multicenter clinical trials. Control Clin Trials. 21:2000;21-29.
16. Ciminera J.L., Heyse J.F., Nguyen H., Tukey J.W. Evaluation of multicentre clinical trial data using adaptations of the Mosteller-Tukey procedure. Stat Med. 12:1993;1047-1061.
17. Jones B., Teather D., Wang J., Lewis J.A. A comparison of various estimators of a treatment difference for a multi-centre clinical trial. Stat Med. 17:1998;1767-1777.
18. Gail M., Simon R. Testing for qualitative interaction between treatment effects and patient subsets. Biometrics. 41:1985;361-372.