Question 1: 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?
Question 2: 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).
Question 3: 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?
Question 4: Why might crossover occur in some clinical trials?