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Activity Number:
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135
- Multiplicity, Missing Data and Other Topics
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Type:
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Contributed
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Date/Time:
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Monday, August 9, 2021 : 1:30 PM to 3:20 PM
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Sponsor:
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Biopharmaceutical Section
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Abstract #317944
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Title:
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A Bias Correction Method for Hazard Ratio Estimation and Its Inference in a Multiple-Arm Clinical Trial
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Author(s):
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Liji Shen and Ziwen Wei and Xuan Deng*
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Companies:
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Merck & Co. Inc and Merck & Co. Inc and Merck & Co. Inc
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Keywords:
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Multiple testing;
multi-arm clinical trial;
time to event endpoint;
hazard ratio;
stepwise overcorrection (SOC)
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Abstract:
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A randomized clinical trial with multiple arms is often used to speed up development to select the best experimental regimen or to increase the chance of success of clinical trials. Most of time, multiple dose levels of an experimental drug or multiple combinations of one experimental drug with other drugs are comprised of the multiple experimental groups. Because the experimental drug appears in multiple comparisons with a shared control group, multiple testing adjustment to control the family-wise type I error rate is needed. We extend the Stepwise Over-Correction method that is applied to a multi-arm trial with a response rate as its endpoint to a multi-arm trial where time to event is the primary endpoint and confidence interval of the hazard ratio determines the statistical significance. We provide the formula of the bias of the maximum treatment effect towards the true treatment effect between the selected experimental group and the shared control group. The type I error control and the power enhancement of the proposed approach are both held.
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Authors who are presenting talks have a * after their name.
