Applied Statistics in the Pharmaceutical Industry pp 299-320 | Cite as
Comparing Two Treatments in a Large Phase III Clinical Trial
Abstract
This chapter outlines some of the analyses performed for a Phase III oncology trial. The trial was conducted by F. Hoffmann-La Roche and took place between 1996 and 1998. More than 600 cancer patients receiving either a new experimental therapy or a standard treatment were included in the trial. Besides a description of the data, the statistical analysis methods used for some of the analyses are detailed (with an emphasis on survival analysis). The applications of the methods using S-Plus are outlined. The focus is on the analyses as specified in the trial protocol. Due to space limitation, not all analyses performed for the trial are mentioned and not all aspects of the trial are presented.
Keywords
Experimental Treatment Metastatic Site Partial Responder Complete Responder Tumor AssessmentPreview
Unable to display preview. Download preview PDF.
References
- Ellenberg, S.S. and Hamilton, J.M. (1989). Surrogate endpoints in clinical trials: Cancer. Statistics in Medicine 8, 405–413.CrossRefGoogle Scholar
- Hauck, W.W. and Anderson, S. (1986). A comparison of large-sample confidence interval methods for the difference of two binomial probabilities. The American Statistician 40, 318–322.Google Scholar
- International Conference on Harmonization (1998). Topic E 9: Statistical Prin- ciples for Clinical Trials, Step 4, Consensus Guideline. 5 February 1998.Google Scholar
- Schouten, H.J.A., Molenaar, I.W., Strik, R. van, and Boomsma, A. (1980). Comparing two independent binomial proportions by a modified chi square test. Biometrical Journal 22, 241–248.MATHCrossRefGoogle Scholar
- Venables, W.N. and Ripley, B.D. (1997). Modern Applied Statistics with S-PLUS, 2nd ed. Springer-Verlag, New York.Google Scholar
- World Health Organization-Geneva (1979). WHO Handbook for Reporting Results of Cancer Treatment.Google Scholar