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Activity Number:
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238
- Addressing Nonproportional Hazards Issues in Oncology Clinical Trial Design
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Type:
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Topic-Contributed
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Date/Time:
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Wednesday, August 11, 2021 : 10:00 AM to 11:50 AM
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Sponsor:
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Biopharmaceutical Section
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Abstract #317311
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Title:
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New alternative measures to hazard ratio
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Author(s):
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HAJIME UNO*
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Companies:
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Dana-Farber Cancer Institute
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Keywords:
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non-proportional hazard;
delayed difference;
immunotherapy;
restricted mean survival time
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Abstract:
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The hazard ratio (HR) has been the most popular measure to quantify the magnitude of treatment effect on time-to-event outcomes in clinical research. However, the HR estimated by Cox's method has several drawbacks. One major issue is that there is no clear interpretation when the proportional hazards (PH) assumption does not hold. Another significant issue is the lack of a reference number from the control group. We review several alternative methods in this talk and propose a new approach that does not have these significant issues. Numerical studies demonstrated that the proposed technique offers almost identical power to Cox's method under PH scenarios and can be more efficient for delayed-difference patterns often seen in immunotherapy trials.
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Authors who are presenting talks have a * after their name.
