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Activity Number:
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185
- Novel Methods for Clinical Trial Design and Characterizing Heterogeneity
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Type:
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Contributed
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Date/Time:
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Tuesday, August 4, 2020 : 10:00 AM to 2:00 PM
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Sponsor:
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Section on Bayesian Statistical Science
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Abstract #311145
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Title:
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A Novel Power Prior Approach to Borrowing Historical Control Data in Clinical Trials
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Author(s):
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Yaru Shi* and Wen Li and Guanghan Frank Liu
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Companies:
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Merck & Co. and Merck and Merck Inc.
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Keywords:
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Bayesian statistics;
Power prior;
Historical data;
Clinical trials
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Abstract:
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There has been an increased interest in borrowing information from historical control data in improving the statistical power for hypothesis testing, therefore reducing the required sample sizes in clinical trials. To account for the heterogeneity between the historical and current trials, existing power prior approaches are often considered to discount the information borrowed from the historical data by choosing a fixed power prior parameter, which can be challenging in the applications. In this paper, we propose a novel approach to pick a power prior based on some direct measures of distributional differences between historical control data and current control data under normal assumptions. Simulations are conducted to investigate the performance of the proposed approach compared with current approaches. The results show that the proposed power prior improves the study power while maintaining the type I error when the distribution of the historical control data is similar to that of the current control data. The method is developed for both superiority and non-inferiority trials and is illustrated with an example in vaccine clinical trials.
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Authors who are presenting talks have a * after their name.
