All Times EDT
Keywords: TREATMENT SWITCH, IPCW, RPSFTM
It’s not uncommon to see in oncology trials that a higher proportion of patients in the control arm switch over to a subsequent anti-cancer therapy after treatment discontinuation, compared to patients in the experimental arm. The high degree of imbalance in subsequent anti-cancer therapy use between treatment arms will impact the assessment of treatment effect. Sensitivity analyses correcting for this confounding effect would be important. In the EMA document “Question and answer on adjustment for cross-over in estimating effects in oncology trials”, several exploratory analysis methods were suggested (such as Inverse Probability of Censoring Weighting (IPCW) and Rank Preserving Structural Failure Time Models (RPSFTM)) . In this poster, we will apply these methods to a Phase 3 oncology trial and discuss the pros and cons of each method.