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Activity Number: 153 - Utilization of Historical Data for Confirmatory Trials
Type: Topic Contributed
Date/Time: Tuesday, August 4, 2020 : 10:00 AM to 11:50 AM
Sponsor: Biopharmaceutical Section
Abstract #311060
Title: Historical Data Borrowing with Informative Inferential Prior for Bayesian Hypothesis Testing
Author(s): Hui Quan* and Bingzhi Zhang and Yu Lan and Xiaodong Luo and Xun Chen
Companies: Sanofi and Sanofi and Sanofi and Sanofi and Sanofi
Keywords: inferential prior; interim analysis; historical data borrowing; power

Bayesian methodologies have become more and more popular for their applications to clinical trials. Nonetheless, the reconciliation of the formulation of the hypotheses and the calculation of type I error between a Bayesian analysis and traditional frequentist analysis is still not very clear. In this research, we apply inferential prior, null prior and design prior to the Bayesian analysis, type I error control and sample size calculation. As demonstrated, the type I error control denies any borrowing of favorable prior information. Thus, the use of the calibrated critical value obtained through simulation for the commensurate or power prior for a Bayesian analysis has the effect of eliminating the borrowing of historical information. The validity of a Bayesian analysis with the borrowing of historical data should rest on the a priori assumption of consistency of data from the historical and current studies. Just in case the consistency assumption is not totally true, dynamic borrowing can regulate the level of borrowing based on the degree of consistency in the data. An example along with simulations are used to illustrate the applications of the methods.

Authors who are presenting talks have a * after their name.

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