WITHDRAWN: Tools for Randomized Clinical Trials Using Restricted Mean Survival Time and Average Hazard

Music City Center 

In randomized clinical trials with time-to-event outcomes, the log-rank test based on Cox's proportional hazards (PH) model is commonly used for statistical comparisons, with the hazard ratio (HR) reported as the summary measure of treatment effect. However, the limitations of this traditional approach have been widely discussed. Alternative methods, such as restricted mean survival time (RMST) and average hazard with survival weight (AH), are gaining attention to address the limitations and providing more robust and interpretable quantitative information on treatment effects. While they have received attention, practical considerations for trial design using RMST or AH, particularly in determining analysis timing, remain understudied. We aim to fill these gaps by presenting methodological considerations and tools for identifying analysis timing, aiming to facilitate broader adoption of these alternative methods in practice.

non-proportional hazards

survival analysis

time-to-event outcomes

clinical trials

study design 

Biopharmaceutical Section