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Robust Design and Analysis of Clinical Trials With Nonproportional Hazards: A Straw Man Guidance From a Cross-Pharma Working Group
Loss of power and clear description of treatment differences are key issues in designing and analyzing a clinical trial where nonproportional hazard (NPH) is a possibility. A log-rank test may be inefficient and interpretation of the hazard ratio estimated using Cox regression is potentially problematic. In this case, the current …