Comparing Two Treatments in a Large Phase III Clinical Trial
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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.
KeywordsExperimental Treatment Metastatic Site Partial Responder Complete Responder Tumor Assessment
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