Problem
A. Describe the characteristics of an ideal primary outcome/target clinical outcome and identify some of the common issues associated with using these ideal primary outcomes in clinical trials.
B. Does primary outcomes used in Choueiri 2021 and Sax 2012 meet the requirements of an ideal primary endpoint or are they representative of a surrogate endpoint?
C. Review the Kaplan-Meier overall survival and progression free survival plots for the IMDC intermediate and poor-risk patients as provided in Choueiri 2021 for the comparison of Nivolumab & Cabozanitinib vs Sunitinib. Provide a description of the characteristics of these plots based on visual inspection supported by estimates from the plots (e.g. 12 month survival).
D. What statistical analyses are reported in Choueiri 2021 with regards to the outcomes of overall survival for the comparison of Nivolumab & Cabozantinib vs Sunitinib (IMDC intermediate and poor risk subjects; primary analysis). How would you interpret these results?
E. Why might crossover occur in some clinical trials?