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Abstract:
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Many clinical trials are designed with plenty of historical control data available. To reduce the ever-increasing cost and timeline of the drug clinical development, historical control data are proposed to be incorporated in clinical trial design and analyses. Many statistical methodologies have been proposed, Bayesian and frequentist. Bayesian methods include power prior approach, commensurate prior approach and mixture prior approach. In this presentation, we will discuss a newly proposed statistical approach which combines elements of all the three approaches mentioned above, but admits a closed-form formula for easy implementation. We will demonstrate the approach with a case study and share our interaction experiences with regulatory agencies.
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