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Activity Number:
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278
- Multi-Stage and Seamless Clinical Trials
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Type:
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Contributed
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Date/Time:
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Tuesday, August 9, 2022 : 10:30 AM to 12:20 PM
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Sponsor:
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Biopharmaceutical Section
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Abstract #322408
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Title:
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Two-Stage in Restricted Mean Survival Time with Conditional Power in Clinical Studies
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Author(s):
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Jingyu Huang* and Yong Lin and Weichung Joe Shih and Shou-en Lu and Kaifeng Lu
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Companies:
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Rutgers University and Rutgers University and Rutgers University and Rutgers University and Allergan
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Keywords:
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Restricted Mean Survival Time;
Conditional Power;
Clinical Studies;
Non-proportional Hazard
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Abstract:
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In clinical trials, two stage design is commonly used to dismiss ineffective treatment early at the end of the first stage, in order to avoid the high cost and long trial duration. Conditional Power (CP) is the conditional probability of a significant result at the end of the trial given the data observed thus far. It is commonly used to evaluate the possibility of stopping the trial for futility. It also can be used to perform sample size re-estimation (SSR) at the interim stage. The Restricted Mean Survival Time (RMST) is a robust measure of the survival time distribution. It provides a clinically interpretable summary and is widely used in the non-proportional hazards situation, since it does not rely on the PH assumption. This presentation describes how to calculate the CP for the RMST endpoint at the interim stage for non-proportional hazards models. An approach for predicting survival curve at the final stage is developed in order to calculate the correlation in test statistics between the interim and final stages.
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Authors who are presenting talks have a * after their name.
