Pros and cons of permutation tests in clinical trials

Statistics in Medicine

Volumn 19, Issue 10, 2000, Pages 1319-1328

  Berger, Vance W ^a,b  

^a NATIONAL CANCER INSTITUTE   (United States)

^b CENTER FOR BIOLOGICS EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CLINICAL TRIAL; HYPOTHESIS; MEDICAL RESEARCH; METHODOLOGY; STATISTICAL ANALYSIS; VALIDATION PROCESS;

HUMANS; MODELS, STATISTICAL; RANDOMIZED CONTROLLED TRIALS;

EID: 0034732875     PISSN: 02776715     EISSN: None     Source Type: Journal    
DOI: 10.1002/(SICI)1097-0258(20000530)19:10<1319::AID-SIM490>3.0.CO;2-0     Document Type: Article

References (28)

1. Fisher LD, Moye LA. Carvedilol and the Food and Drug Administration approval process: an introduction. Controlled Clinical Trials 1999; 20:1-15.
2. Fisher LD. Carvedilol and the Food and Drug Administration approval process: the FDA paradigm and reflections on hypothesis testing. Controlled Clinical Trials 1999; 20:16-39.
3. Moye LA. End-point interpretation in clinical trials: the case for discipline. Controlled Clinical Trials 1999:20:40-49.
4. Ludbrook J, Dudley H. Why permutation tests are superior to t and F tests in biomedical research. American Statistician 1998; 52(2):127-132.
5. Feinstein AR. Permutation tests and statistical significance. MD Computing 1993; 10(1):28-41.
6. Edgington ES. Randomization Tests, third edn. Marcel Dekker: New York, 1995.
7. Tukey J. Tightening the clinical trial. Controlled Clinical Trials 1993; 14:266-285.
8. Senn S. Fisher's game with the Devil. Statistics in Medicine 1994; 13:217-230.
9. Kolata GB. Controversy over study of diabetes drugs continues for nearly a decade. Science 1979; 203:986-990.
10. Elwood JM. Critical appraisal of epidemiological studies and clinical trials. Oxford University Press: Oxford, 1998.
11. Royall RM. Comment on Hansen et al. Journal of the American Statistical Association 1983; 78:794-796.
12. Koch GG, Edwards S. Clinical efficacy trials with categorical data. In Biopharmaceutical Statistics for Drug Development, Peace KE (ed.). Marcel-Dekker: New York, 1988.
13. Leber PD, Davis CS. Threats to the validity of clinical trials employing enrichment strategies for sample selection. Controlled Clinical Trials 1998; 19:178-187.
14. Fisher LD, van Belle G. Biostatistics. Wiley: New York, 1993.
15. Mike V. Understanding uncertainties in medical evidence: professional and public responsibilities. In Acceptable Evidence, Mayo DG, Hollander RD (eds). Oxford University Press: New York, 1991.
16. Senn SJ. Falsificationism and clinical trials. Statistics in Medicine 1991; 10:1679-1692.
17. Royall RM. Ethics and statistics in randomized clinical trials (with comments). Statistical Science 1991; 6(1):52-88.
18. Olschewski M, Schumacher M, Davis KB. Analysis of randomized and nonrandomized patients in clinical trials using the comprehensive cohort follow-up study design. Controlled Clinical Trials 1992; 13:226-239.
19. Berger VW, Permutt T, Ivanova A. The Convex Hull Test for ordered categorical data. Biometrics 1998; 54(4):1541-1550.
20. Kimball AW. Error of the third kind in statistical consulting. Journal of the American Statistical Association 1957; 52:133-142.
21. Senn S. Statistical Issues in Drug Development. Wiley: Chichester 1997.
22. Bross I. Comment on Birnbaum. Journal of the American Statistical Association 1962; 57:298, 309-311.
23. Bross ID. How to eradicate fraudulent statistical methods: statisticians must do science. Biometrics 1990; 46:1213-1225.
24. Salsburg DS. The Use of Restricted Significance Tests in Clinical Trials. Springer-Verlag: New York, 1992.
25. Mehta CR. The exact analysis of contingency tables in medical research. In Recent Advances in Clinical Trial Design and Analysis, Thall P (ed.). Kluwer: Boston, 1995.
26. Gail MH, Mark SD, Carroll RJ, Green SB, Pee D. On design considerations and randomization-based inference for community intervention trials. Statistics in Medicine 1996; 15:1069-1092.
27. Cox DR. Some problems connected with statistical inference. Annals of Mathematical Statistics 1958; 15:357-372.
28. Temple RJ. Special study designs: early escape, enrichment, studies in non-responders. Communications in Statistics 1994; 23(2):499-531.