Keywords: Non-proportional Hazards
The NPH problem is beyond an analytical concern. For clinical trials with main endpoints of interest based on the time-to-event data, the underlying NPH problem poses challenges across the span of the design, operation, analysis and reporting. It is recommended to have a well-thought-out “NPH strategy” earlier during the trial planning phase and incorporate it into the strategic considerations of the late-stage clinical program. This presentation attempts to provide a holistic review and discussion on the creation and implementation of NPH strategies, and is organized as the following parts: (1) Clarify and align your “NPH Philosophy”: to PH, or not to PH; (2) pitfalls around NPH during the design and planning; (3) the journey of finding the “best NPH Method”; (4) the proposals and reality check.