Discussion of "some controversial multiple testing problems in regulatory applications" by H. M. J. Hung and S.-J. Wang

Journal of Biopharmaceutical Statistics

Volumn 19, Issue 1, 2009, Pages 25-34

  Bretz, Frank ^a,b   Maurer, Willi ^a   Gallo, Paul ^a  

^a NOVARTIS PHARMA AG   (Switzerland)

^b HANNOVER MEDICAL SCHOOL   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

ANALYTICAL ERROR; CLINICAL PRACTICE; CLINICAL STUDY; DRUG DEVELOPMENT; HUMAN; MATHEMATICAL ANALYSIS; MEDICAL RESEARCH; NOTE; PRIORITY JOURNAL;

EID: 60749103221     PISSN: 10543406     EISSN: 15205711     Source Type: Journal    
DOI: 10.1080/10543400802541834     Document Type: Note

References (15)

1. Bowden, J., Glimm, E. (2008). Unbiased estimation of selected treatment means in two-stage trials. Biometrical Journal 50(4):515-527.
2. Bretz, F., Maurer, W., Brannath, W., Posch, M. (2009). A graphical approach to sequentially rejective multiple test procedures. Statistics in Medicine (in press).
3. FDA Guidance for Industry. (2006). Clinical studies section of labeling for prescription drugs and biologics. Available from: www.fda.gov/cder/guidance/ 5534fnl.htm.
4. FDA Guidance for Industry. (2007). Clinical data needed to support the licensure of seasonal inactivated influenza vaccines. Available from: www.fda.gov/cber/gdlns/trifluvac.htm.
5. Gerstein, H. C., Yusuf, S., Holman, R., Bosch, J., Pogue, J. The DREAM Trial Investigators (2004). Rationale, design and recruitment characteristics of a large, simple international trial of diabetes prevention: the DREAM trial. Diabetologia 47:1519-1527.
6. Hochberg, Y., Tamhane, A. C. (1987). Multiple Comparison Procedures. New York: Wiley.
7. Hsu, J. C. (1996). Multiple Comparisons. London: Chapman and Hall.
8. Koch, G. (2000). Discussion for "Alpha calculus in clinical trials: considerations and commentary for the new millennium" by L. A. Moyé. Statistics in Medicine 19:781-784.
9. Lee, I.-M., Cook, N. R., Gaziano, M., Gordon, D., Ridker, P. M., Manson, J. E., Hennekens, C. H., Buring, J. E. (2005). Vitamin E in the primary prevention of cardiovascular disease and cancer; the women's health study: a randomized controlled trial. JAMA 294:56-65.
10. Maca, J., Gallo, P., Branson, M., Maurer, W. (2002). Reconsidering some aspects of the two-trials paradigm. Journal of Biopharmaceutical Statistics 12(2):107-119.
11. Marcus, R., Peritz, E., Gabriel, K. R. (1976). On closed testing procedures with special reference to ordered analysis of variance. Biometrika 63:655-660.
12. MRC/BHF heart protection study collaborative group: MRC/BHF heart protection study of cholesterol-lowering therapy and of antioxidant vitamin supplementation in a wide range of patients at increased risk of coronary heart disease death: early safety and efficacy experience. (1999). Eur. Heart. J. 20:725-741.
13. Ridker, P. M., Cook, N. R., Lee, I.-M., Gordon, D., Gaziano, J. M., Manson, J. E., Hennekens, C. H., Buring, J. E. (2005). A randomized trial of low-dose aspirin in the primary prevention of cardiovascular disease in women. NEJM 352:1293-1304.
14. Strassburger, K., Bretz, F. (2008). Compatible simultaneous lower confidence bounds for the Holm procedure and other Bonferroni based closed tests. Statistics in Medicine 27:4914-4927.
15. Westfall, P. H., Bretz, F. (2003). Multiplicity in clinical trials. In: Chow, S. C., ed. Encyclopedia of Biopharmaceutical Statistics. 2nd ed. New York: Marcel Dekker Inc., pp. 666-673.